New drug shows promise in multiple sclerosis treatment, researchers say

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(CBS News) There's a new treatment for multiple sclerosis, or MS, which affects more than 400,000 Americans.

MS can strike anyone at any time, but it usually hits adults in the prime of their lives. But researchers say a new drug is proving very promising.

FDA approves new multiple sclerosis treatment Aubagio

As an electrician, 49-year-old Stephen O'Malley depends on good vision. But seven years ago, things suddenly began to go dark.

O'Malley recalled, "I was scared to death. I went to work at 6:00 in the evening and I was completely blind in one eye six hours later."

The Cleveland father of two was diagnosed with MS. MS is a neurological disease that affects the brain and spinal cord. Symptoms can range from numbness and tingling to blindness and paralysis. They usually get worse over time, leaving many patients greatly disabled.

While there is no cure for MS, there are effective treatments. Kate Lodge gets monthly infusions requiring a two-hour visit to the hospital, but there are scary potential side effects, including fatal brain infections.

"The symptoms of the brain infection can mirror the symptoms of MS, so you can't know," Lodge said. "And so you go into a panic mode."

Dr. Robert Fox is medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis. He said what was needed in an MS treatment is a combination of effective therapy that's well tolerated and safe.

And now, that therapy may finally be here in an easy-to-take pill form.

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New drug shows promise in multiple sclerosis treatment, researchers say

Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model – A Novel Oral Small Molecule Approach for the …

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GENEVA--(Marketwire - Sep 24, 2012) - Addex Therapeutics / Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model - A Novel Oral Small Molecule Approach for the Treatment of Multiple Sclerosis.

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The issuer is solely responsible for the content of this announcement.

Addex Therapeutics (SIX: ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today achievement of a positive Proof of Concept for its lead metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) compound series in a validated rodent model for multiple sclerosis (MS). MS is a chronic inflammatory demyelinating auto-immune disease that affects the central nervous system (CNS), leading to serious disability.

"We are very excited that this promising Addex mGluR4 PAM series may offer a differentiated approach to treating MS," said Professor Ursula Grohmann, of University of Perugia, Italy, in whose laboratories one of these studies was performed. "These data confirm our previous observations, using an mGluR4 PAM tool compound called PHCCC, which demonstrated efficacy in the industry standard neuroinflammation model of MS, the Relapsing-Remitting Experimental Allergic Encephalomyelitis (RR-EAE) model. In this study, the mGluR4 PAM worked by promoting regulatory T-cell (Treg) formation and reversing pro-inflammatory T-cell release. Therefore, we believe that positive modulation of mGluR4 could potentially stop the destruction of myelin in MS in a robust and durable manner."

Addex lead chemical series is a highly selective orally available mGluR4 PAM and shows good pharmacokinetic properties for potential once-daily dosing. When administered once a day for 3 weeks at 10, 30 and 60 mg/kg sc, Addex mGluR4 PAM demonstrated a dose-dependent, statistically significant reduction in paralysis (clinical score) and the relapse rate in the RR-EAE model of MS in mice. The presentation of these data is being planned for a major international conference.

"Current MS therapies are primarily focused on reinstating motor function after an inflammatory attack, preventing new attacks, and preventing or treating disability and symptoms, such as spasticity. In addition, most of these therapies are primarily based on immunomodulatory strategies, and have serious compliance-limiting side effects", noted Graham Dixon, CSO of Addex Therapeutics. "We believe a well-tolerated, oral mGluR4 PAM would represent a major advance in the treatment of MS because of the novel and potentially broader mechanism; having the potential to not only treat symptoms, but slow disease progression and offer neuroprotection. We are now rapidly advancing this lead series towards a clinical candidate and conducting experiments to further elucidate the biological role of mGluR4 PAM in MS."

"Moving the lead compound from this series into full development in 2012 clearly illustrates our strategy of advancing innovative novel selective oral small molecule drug candidates against previously "undruggable" targets" said Bharatt Chowrira, CEO of Addex Therapeutics. "These data along with the recently announced data on the role of the mGluR4 PAMs in Parkinson's disease, the positive Phase 2 data for dipraglurant in Parkinson's disease levodopa-induced dyskinesia, the two Phase 2 clinical trials being conducted by our partner Janssen, and our GABABR PAM program advancing towards an IND filing later this year, demonstrate the power of Addex platform that continues to generate multiple, novel high value product opportunities."

About Multiple Sclerosis

Multiple sclerosis, is an idiopathic inflammatory disease of the central nervous system, characterized pathologically by demyelination and subsequent axonal degeneration. The disease commonly presents in young adults and affects twice as many women as men. Common presenting symptoms include numbness, weakness, visual impairment, loss of balance, dizziness, urinary bladder urgency, fatigue, and depression. Approximately 2.5 million people worldwide are affected with prevalence ranging from 2 and 150 per 100,000, depending on the country and specific population. MS takes several forms. The most common affecting around 85 per cent of everyone diagnosed with MS is relapsing remitting MS (RRMS). It means that symptoms appear (a relapse), and then fade away, either partially or completely (remitting). Secondary progressive MS (SPMS) is a stage of MS which comes after RRMS in many cases. Although the pathogenesis of MS is complex and not fully understood, it is believed that RRMS is characterized by repeated episodes of inflammation which eventually leads to the axonal degeneration through damage to, and loss of the myelin sheath characteristic of SPMS. Given the prominence of immune generated inflammation in MS, treatments for the disease have focused particularly on immunosuppressive anti-inflammatory strategies. Currently approved treatments for RRMS are only partially effective in reducing MS relapses and in particular do not halt disability progression. As these drugs alter immune function, patients can experience serious and sometimes life threatening side effects (e.g. opportunistic infections, emergent malignancies, alopecia, cardiotoxicity and myelosuppression). Furthermore, many of these agents also require regular injection, or parenteral infusions which are uncomfortable and inconvenient for the patient.

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Addex mGluR4 Allosteric Modulator Effective in Multiple Sclerosis Model - A Novel Oral Small Molecule Approach for the ...

Harmons Donates nearly $245,000 to National MS Society

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Harmons Grocery Stores has given $244,287 to the Utah-Southern Idaho Chapter of the National Multiple Sclerosis (MS) Society as part of the food chains 80th anniversary celebration.

The West Valley City-based chain raised money in May and June for the local non-profit by collecting donations at check stands, selling bratwursts and hot dogs on the weekends, hosting a charity golf tournament and sponsoring a bike team. All proceeds will go directly to the local National MS Society chapter.

"We are incredibly grateful to Harmons for getting behind Bike MS and going over the top every year in raising funds for our programs," said Royle-Mitchell, MS chapter president "Utah has one of the highest incidence rates of multiple sclerosis in the nation and the funds raised by Harmons will support critical research, information and referral programs, professional and community education, financial assistance, scholarships, wellness programs, advocacy, support groups and a lending library."

The National MS Society seeks a world free of multiple sclerosis. Every hour someone is newly diagnosed with MS, a chronic, unpredictable often disabling disease of the central nervous system. It is estimated that one in 300 Utahns has MS.

Harmons is one of Utahs few remaining locally-owned and operated grocery chains. It supports local charities throughout the year and is one of the largest contributors in the state to Special Olympics Utah, the National MS Society and the Utah Food Bank.

Copyright 2012 The Salt Lake Tribune. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Harmons Donates nearly $245,000 to National MS Society

Experimental multiple sclerosis pill reduces flare-ups in studies, adding hopes for new treatment option

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New drug shows promise in multiple sclerosis treatment, researchers say FDA approves new multiple sclerosis treatment Aubagio Commonly prescribed interferon beta does not delay multiple sclerosis progression in study

Each week 200 or more Americans are diagnosed with multiple sclerosis, according to the National Multiple Sclerosis Society. The autoimmune disease causes the body's natural defenses to attack the central nervous symptom, resulting in symptoms that range from mild, including numbness in the limbs, to severe symptoms like disability, loss of vision or paralysis. Most people are diagnosed between 20 and 50, NMSS says.

There are four types of MS, with 85 percent of patients initially diagnosed with what's called relapsing-remitting MS. People with relapsing-remitting MS often have attacks - called relapses, flare-ups or exacerbations - that may worsen neurological function, which are followed by partial or complete recovery (remission) periods.

The trials for BG-12 were phase III, which is often the step closest to a drug's approval when scientists gather more data on its safety and efficacy. BG-12 is manufactured by Massachusetts based-Biogen Idec, which is seeking FDA approval on the drug. The drugmaker funded the new studies, which were published online Sept. 20 in the New England Journal of Medicine.

The first study - known as the DEFINE trial - looked at 1,200 people to determine whether a BG-12 pill could reduce the frequency of relapses compared to people with MS who were taking a placebo pill.

Participants were split into three groups: those taking 240 milligrams of the pill twice a day, those taking 240 milligrams three times a day and those taking a placebo. At two years, both groups taking BG-12 experienced significant reductions in relapses (49 percent and 50 percent reductions respectively) compared with placebo-takers.

Taking BG-12 also led to significant reductions in risk of MS progressing to disability for the patients. MRI scans confirmed pill-takers had fewer new or active MS lesions than scans of people taking placebo.

The next trial, led by Dr. Robert J. Fox, medical director at the Cleveland Clinic's Mellen Center for Multiple Sclerosis, included 1,400 people with MS to determine whether BG-12 could reduce the average yearly relapse rate for patients at two years.

Similar to DEFINE, this study - known as the CONFIRM trial - measured relapse rates of patients taking either a 240 milligram dose of BG-12 twice a day or three times a day, comparing them a group taking placebo. A fourth group was assigned to receive the injectable MS drug, glatiramer acetate, which is sold as Copaxone and was FDA-approved in 1996 to reduce the frequency of relapses in patients with relapsing-remitting MS.

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Experimental multiple sclerosis pill reduces flare-ups in studies, adding hopes for new treatment option

Dozens walk to support Multiple Sclerosis cause

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Readmore: Local, Health, Education, Community, Economy, News, Science, Technology, MS, Multiple Sclerosis, People Living with MS, Walk to End MS, Superior Dome, Fight MS, Marquette, Cause, Community Outreach

MARQUETTE -- Dozens who helped an important cause in Marquette this Sunday didn't have to worry about the rain in order to do so. They did it all inside the Superior Dome.

This is the first walk the regional Multiple Sclerosis organization has done in a few years. The walk for Multiple Sclerosis is part of a national push that supports cutting edge research and providing services to help people with MS move their lives forward.

"The money for this walk and for MS in general is very important for research and hopefully to find a cure," said Lisa Taylor, an organizer and head of the local support group in Marquette.

"And it goes to people who can't afford medication, or people who need walkers or canes or wheelchairs."

To find out more about their cause, click here.

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Multiple sclerosis patients, doctors appreciate help from Ann Romney, Michelle Obama

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By Irene Maher, Times Staff Writer Irene MaherTampa Bay Times In Print: Monday, September 17, 2012

Regardless of your political leanings, at least one group of Americans was grateful for the Republican and Democratic National Conventions: Those affected by MS.

People with multiple sclerosis appreciated the shout-out from Ann Romney, wife of presidential nominee Mitt Romney, at the Republican National Convention in Tampa and from first lady Michelle Obama with the Democrats a week later in Charlotte, N.C.

Romney has been living with MS since 1998. Obama's father lived with the disease for about 30 years before his death at age 66. Both women related how their lives were affected by MS.

That kind of exposure does more than increase awareness of an often misunderstood disease that afflicts 400,000 Americans, experts said.

"In the case of Ann Romney, seeing someone at the podium, in the national spotlight, living an obviously busy, active life allows others to see how much you can accomplish with MS," said Dr. Stanley Krolczyk, director of the multiple sclerosis division in the department of neurology at USF Health. "It puts a different face on the disease when celebrities, like Montel Williams and Clay Walker, for example, go public and talk about living with MS."

Jzon Livingston Sr., a patient of Krolczyk's, agrees. The 33-year-old self-employed IT administrator was diagnosed with MS four years ago. With treatment, he's been able to continue working and keep up with his three children, ages 15, 13 and 11. Livingston was moved when Obama described watching the decline in her father.

"That's what the average person needs to know about MS. It's a hard disease to have," he said. "Without knowledge of how it can affect lives, there's no understanding. Without understanding, there's no action."

Multiple sclerosis is a chronic disease of the central nervous system that targets the brain, spinal cord and optic nerves. It can range from mild to severe, where the patient is paralyzed or blind. The disease is unpredictable, and symptoms may start suddenly and persist, then resolve. Sometimes, it seems to be dormant and patients may go months or years without a flare-up. Others, though, have symptoms all the time.

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Multiple sclerosis patients, doctors appreciate help from Ann Romney, Michelle Obama

Local Woman Joins Battle Against Multiple Sclerosis

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Twin Falls, Idaho (KMVT-TV) Tammy Lynard of Filer was diagnosed with multiple sclerosis seven years ago.

She says her brain sends messages that her muscles don't always get. She tires easily and the heat bothers her. Lynard takes a shot every day, but she wants to help find a cure for MS.

Lynard says, "It was kind of a shock when you first hear about it. You try to get as much information as possible. You see the neurologist, they get you on therapies, hopefully as soon as possible. Hopefully the therapies help you live a better life."

Like any other medical condition, MS can affect different people to different degrees. Lynard says one out of every 300 people in idaho have multiple sclerosis.

Lynard says, "The MS Society is great with information, they tell you how to get involved, what to do. I heard about the Walk that first year, and I met a lot of people. I found out there's a lot of people in this area that have the disease. In fact, we're one of the highest in the nation."

You can sign up for Saturday's "Walk MS" in Twin Falls online at walkmsidaho.org , or you can call 1 (800) FIGHT MS, and select option two.

Walk MS will be held this Saturday at the Twin Falls Visitor Center near the Perrine Bridge. Registration starts this Saturday at 8:30 a.m., and the walk begins at ten o'clock.

Walk MS is free to participate in, but the organizers encourage you to raise some money to benefit the cause.

Sept. 19, 2012.

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Local Woman Joins Battle Against Multiple Sclerosis

Former Longhorn Earl Campbell gives donation to National Multiple Sclerosis Society

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By Liz Farmer

A scholarship supported by University of Texas football legend Earl Campbell and his son Tyler Campbell could make it easier for students affected by multiple sclerosis to finish college.

Earl Campbell, NFL Hall of Fame running back and Heisman Trophy winner, announced Tuesday that he and his son have raised $60,000 for the nonprofit National Multiple Sclerosis Society to provide scholarships for college students who have MS or who have a parent with MS. The society reports it has awarded $187,000 in scholarships to 22 Texas students this year.

MS is a chronic disease of the central nervous system that interrupts information flow between the body and the brain with symptoms including limb numbness, paralysis and vision loss. Campbell's son was diagnosed with MS while at San Diego State University.

The Campbells raised part of the scholarship funds through sales of "The Unstoppable Earl Campbell," a Warner Bros. piece of art signed by Earl Campbell that depicts him in UT gear running a football past cartoon characters including Bugs Bunny and Yosemite Sam.

"I feel very happy that my son and our family has done something to give back," Earl Campbell said. Some money came from benefits such as the Flavors of Austin, which featured local food and drinks. Tyler Campbell said raising money for scholarships is great but he's not satisfied.

"We have to put this disease to rest," he said.

Scholarship recipient Justin Williams is studying for a degree in neurobiology at UT and said he wants to treat people such as his grandmother and father, who both have MS. "My dad's doctor made me truly believe a doctor could change someone's life," Williams said. "I can't thank Earl and Tyler enough."

Bridgette Kieffer, who also got a scholarship, said her mother was diagnosed with MS a few months before she was born. Kieffer said she is pursuing a degree in sociology and English.

"I knew that (college) may not be a possibility because of the cost of medical bills," Kieffer said. "The scholarship has given my family hope and showed us that there's more to life."

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Former Longhorn Earl Campbell gives donation to National Multiple Sclerosis Society

Pill shows promise in suppressing multiple sclerosis relapses

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A new oral medication to treat patients in the early stages of multiple sclerosis has shown considerable promise in two clinical trials, researchers announced Wednesday.

The medication is on track to become just the third oral drug available to MS patients, and potentially the safest and most effective, experts said. The second oral drug, called Aubagio, was approved just last week.

MS was virtually untreatable only two decades ago, but today nine "disease modifying" drugs are available for early-stage patients; a half-dozen more are in the late stages of development. Most patients in the early stage of the disease, a form called relapsing-remitting MS, take drugs intravenously.

The two new studies, published online in The New England Journal of Medicine, found that the drug BG-12, developed by Biogen Idec, reduced relapse rates in patients with relapsing MS by about 50 percent.

The drug also significantly reduced the frequency of new brain lesions often associated with these attacks, and slowed the progression of disease compared with a placebo.

The studies were Phase 3 trials, a last step on the road to drug approval. The Food and Drug Administration is required to make a decision about the drug's approval before the end of this year.

"This drug is clearly quite effective in managing disease and reducing disability, and the safety profile looks quite good," said Timothy Coetzee, the chief research officer at the

Multiple sclerosis is often a progressive disease in which the immune system damages neurons in the brain and spinal cord.

A majority of people with MS have relapsing-remitting MS, characterized by flare-ups that cause lesions in the brain to develop and neurological symptoms to emerge or worsen. Eventually, more than half of patients develop a progressive form of MS, leading to permanent disabilities.

Interferons, the drugs most commonly used in relapsing MS, reduce relapses by about 30 percent, and have not been shown to slow the progression of the disease and disability. The newly approved Aubagio also reduces relapses by about 30 percent, and it has the advantage of being an oral drug.

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Pill shows promise in suppressing multiple sclerosis relapses

Intern – European Multiple Sclerosis Platform

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European Multiple Sclerosis Platform is looking for an intern

The Brussels-based European Multiple Sclerosis Platform (EMSP) is looking for a full-time, paid internship to support the organisation from September 2012 onwards in its Public Affairs and Communications efforts. The envisaged duration of the internship is 6 months, with a possible 3-month extension. The intern will provide support on flagship projects of the EMSP (e.g. further development of our YOUTH project) and contribute to the EMSP's website / web alert as key external communication tools.

Profilea background in communication or EU studies outstanding communication skills and excellent English excellent drafting skills; track-record in contributing to print and online publications a good understanding of European policies and the workings of the EU institutions

Interpersonal skills flexible, can-do attitude well-organised team player yet autonomous

Qualified candidates should submit their CV and cover letter in English to the attention of Christoph Thalheim, Deputy CEO and Director of External Affairs at christoph.thalheim@emsp.org. by the 25th September at the latest. Please note that only short listed candidates will be contacted.

About EMSP The EMSP is representing the interests of 38 national MS societies /patient organisations at the European level, working towards equitable treatment and support for persons with MS throughout Europe. Multiple Sclerosis is the most common debilitating neurological disease of young and middle aged people in Europe. More than 600,000 Europeans are affected.

2012 European voice. All rights reserved.

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Intern - European Multiple Sclerosis Platform

Research and Markets: Global Multiple Sclerosis Drug Pipeline Capsule – 2012

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DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/k4b4f3/global_multiple_sc) has announced the addition of the "Global Multiple Sclerosis Drug Pipeline Capsule - 2012" report to their offering.

This report is an outline of all the key research and development (R&D) activities of the global Multiple Sclerosis drug market. It covers information on key pipeline molecules in various stages of R&D including all the phases of clinical trials, preclinical research, and drug discovery. The report is up-to-date with full coverage of the licensing activities and partnerships.

This report helps executives to keep a track of their competitors and understand their pipeline molecules. The information presented in this report can be used for identifying the partners, prioritizing, evaluating opportunities, developing business development strategies, and executing in-licensing and out-licensing deals.

The report provides information on pipeline molecules by company and mechanism of action across the different stages of R&D. It includes registered / preregistered stage, phase 3 clinical trial, phase 2 clinical trial, phase 1 clinical trial, preclinical research, and drug discovery. It also provides information on pipeline molecules developed in leading geographies including the U.S., Canada, France, Germany, U.K., Italy, and Spain by various stages of R&D. Licensing activities and partnerships in the Multiple Sclerosis drug market is thoroughly covered by company and licensee with the deal summary.

Key Features of the Report:

- Multiple Sclerosis: Overview

- Multiple Sclerosis Drug Pipeline Overview

- Multiple Sclerosis Phase 3 Clinical Trial Drug Pipeline Insights

- Multiple Sclerosis Phase 2 Clinical Trial Drug Pipeline Insights

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Research and Markets: Global Multiple Sclerosis Drug Pipeline Capsule - 2012

Sanofi multiple sclerosis pill gets US approval

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Sanofi SA has won U.S. approval for its multiple sclerosis pill Aubagio - one of the two treatments for the chronic disease that could return the French drugmaker to growth after several blockbuster drugs lost patent protection.

The drug has been shown to be less effective than some rivals but has milder side effects and analysts say it could find favor among newly diagnosed patients. Around 35 percent to 40 percent of multiple sclerosis (MS) sufferers prefer to take no medication rather than face unwanted side effects.

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," Russell Katz, director of the Division of Neurology Products at the Food and Drug Administration, said in a statement on Wednesday.

Aubagio is expected to launch on the U.S. market in a few weeks, a spokeswoman for Sanofi unit Genzyme said.

Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.

MS drugs Gilenya by Novartis and Biogen Idec Inc's BG-12 are expected to dominate a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year.

Aubagio is seen grabbing a much smaller chunk of this market, reaching modest sales of $353 million in the United States and five major European countries by 2020, according to business intelligence firm Datamonitor.

Cheuvreux analyst Marcel Brand, who has a more optimistic forecast, predicts peak sales of Aubagio of 1.48 billion euros by 2018. "Although Aubagio is not as effective on relapse rates as Gilenya, it's free of its longer-term side effects," he said.

Patients taking Gilenya have to be monitored because the drug causes the heart rate to slow down in the first hours after ingestion.

European regulators are expected to give their response to Aubagio in the first quarter of 2013.

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Sanofi multiple sclerosis pill gets US approval

Multiple Sclerosis Pill Approved by U.S. FDA

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The U.S. FDA this week approved a once-a-day pill for the treatment of multiple sclerosis (MS). The pill, being branded as Aubagio by Sanofi S.A., is specifically for the treatment of adults with relapsing forms of MS.

In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo, said Dr. Russell Katz, director of the division of neurology products in the FDAs Center for Drug Evaluation and Research. Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.

According to the National Institutes of Health, MS is a chronic autoimmune disease that affects the central nervous system. It disrupts the communication between the brain and the body, causing motor skill disruption for nearly every part of the body, depending on which nerves in the brain are damaged.

As for the drug itself, side effects seen during drug trials included diarrhea, abnormal liver tests, nausea, and hair loss. Also, the box warnings for the drug warn of possible liver problems and fetal harm, including the risk of birth defects. Doctors will have to check patients liver function and give a pregnancy test before starting treatment with Aubagio.

Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly, said Dr. Aaron Miller, medical director at the center for multiple sclerosis at Mount Sinai Medical Center. The FDAs approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.

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Multiple Sclerosis Pill Approved by U.S. FDA

Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

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Editor's Choice Main Category: Multiple Sclerosis Also Included In: Regulatory Affairs / Drug Approvals Article Date: 15 Sep 2012 - 0:00 PDT

Current ratings for: Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

1.5 (2 votes)

According to experts, the Multiple Sclerosis prescribing market is worth $12 billion annually. If Aubagio becomes popular, it has the potential to become a major earner for its makers, Sanofi-Aventis. However, it is entering a highly-competitive market with very effective existing medications. Novartis' Gilenya and Tysabri from Elan Corp are said to be more effective than teriflunomide.

Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said:

Multiple sclerosis is a long-term autoimmune, inflammatory disease of the central nervous system. Communication between the brain and other parts of the body are disrupted. Multiple Sclerosis is one of the most common causes of neurological disability in young adults. Twice as many females live with MS than males.

People with MS have episodes of relapses (worsening function), followed by remissions (recovery). Eventually, remission periods may be incomplete as the disease progresses. Aubagio has been approved for the initial phases of the disease.

According to clinical trial results, the following side effects among people taking Aubagio were reported: hair loss, nausea, abnormal liver test results, and diarrhea.

Aubagio contains a Boxed Warning explaining to doctors and their patients that there is a risk of liver problems, which may sometimes be fatal, as well as birth defects. Doctors should carry out blood tests beforehand to make sure liver function is normal. During treatment with Aubagio, liver functions tests should be performed periodically.

The Boxed Warning also alerts prescribers and their patients about some animal studies which linked the drug with a higher risk of fetal harm. That is why Aubagio is labeled as a Pregnancy Category X drug, meaning that female patients of childbearing age should have negative pregnancy test results (and use effective birth control therapy) before being considered for Aubagio treatment.

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Aubagio (teriflunomide) Approved For Multiple Sclerosis Treatment, FDA

FDA Approves New Multiple Sclerosis Drug Aubagio

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By Matt McMillen WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 13, 2012 -- The FDA has approved Aubagio (teriflunomide), a new drug for the treatment of multiple sclerosis (MS). The once-a-day tablet will be prescribed to adults with relapsing forms of the chronic, incurable disease.

In a two-year study, the Aubagio reduced yearly relapses by nearly a third compared to placebo. It also slowed the progression of the disease.

"We are greatly encouraged to see a new oral therapeutic option become available to people living with MS," said Timothy Coetzee, PhD, chief research officer at the National MS Society, in a news release issued by the drug's developer, Genzyme.

MS is the most common disabling neurological disease among young adults, according to the National Institute of Neurological Disorders and Stroke. About 400,000 people in the U.S. have MS. As many as two-thirds of them are women. The disease is usually diagnosed between the ages of 20 and 50.

MS often gradually worsens over time. It causes fatigue, pain, vision and muscle problems, and other difficulties.

Aubagio does not come without risks. The drug's label will include a boxed warning that alerts to the risk of potentially fatal liver problems. The label advises that patients' liver function should be tested before starting Aubagio and while on the drug.

The box warning also mentions the risk of birth defects. Women should not be pregnant when they start the drug and must use birth control while taking it.

Other possible side effects include diarrhea, abnormal liver tests, nausea, and hair loss.

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FDA Approves New Multiple Sclerosis Drug Aubagio

Current treatment options for multiple sclerosis

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Multiple sclerosis (MS) is an autoimmune disease that affects approximately 400,000 people in the United States. Caused by damage to the myelin sheath the protective coating of the nerves in the brain MS is marked by an array of symptoms, including muscle spasms, loss of vision and difficulty moving arms and legs.

While there is no cure for MS, there are various treatments available for those suffering from the disease. Dr. Michael Devereaux, a neurologist for University Hospitals Case Medical Center, spoke with FoxNews.com about the many options for MS patients looking for symptom relief. According to him, there are two main goals when it comes to treating MS.

One is treating the acute attacks, Devereaux said. And then, what youre really interested in even more is reducing the frequency of attacks and reducing overall disability over time. Thats been a harder to question to answer from studies and the like, because all the drugs are promoting the idea that they can reduce frequency and overall disability, but theres been some debate about that.

Modifying the disease

During MS, white blood cells, called T-cells, become activated and cross the blood-brain barrier into the brain. While there, they cause an inflammatory response, ultimately damaging the myelin sheath and destroying the axons of the nerves.

Various drugs, called immunologeratory agents, have been developed to dampen the inflammatory response for those with relapsing-remitting MS. The main injectable drugs include beta interferons (Avonex, Betaseron, Extavia), glatiramer acetate (Copaxone), and the somewhat controversial drug, natalizumab (Tysabri)

Tysabri has been in the news a lot because it led to breakouts of another condition progressive multifocal encephalopathy (PML), Devereaux said. Its a very small percentage of cases. Its often given to people not doing well. Its highly effective, but it has this significant, but small, real risk.

The last agent is an oral agent called fingolimod (Gilenya), and is the most convenient for patients, according to Devereaux.

Treating MS attacks

MS is marked by periods of remission, alternating with periods of mild to severe exacerbations. While the agents are used to prevent these flare-ups, there are also treatment options for when exacerbations do occur. The main treatment is to give patients a high dose of glucocorticosteroids

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Current treatment options for multiple sclerosis

Fighting Back -Ordinary People Battling The Everyday Effects Of MS

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Posted on: 7:20 pm, August 31, 2012, by Kelley Hoskins, updated on: 07:14pm, August 31, 2012

ST. LOUIS (KPLR)-A diagnosis of multiple sclerosis doesnt happen to just one person, it affects the whole family. Its a life long disease , and an unpredictable We take a closer look a two ordinary people dealing with life and the ups and downs of the disease. Two very different people with two very different life styles. MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other effectively

One is aprominent St. Louis Pastor the other a local nurse . But what they do have is in common they both are battling multiple sclerosis. Pastor Charles Roach is very active at Trinity Mount Carmel Baptist Church in St. Louis County .He also served his country in the United States Air Force as Staff Sergeant.

Each and every Sunday he delivers a powerful message to his congregation. Pastor Roach says multiple sclerosis runs in his family and he wants to empower , equip and educate others about the disease. Its important that all of us to share an experience of some types of difficulty . It may not be physical as mine but it could be mental or emotional . But one has to learn how to conquer that. We have enough tenacity in us to conquer any difficut situation, said Pastor Roach.

Now we take a look a Michelle Keating a health care provider. a phenomenal women and volunteer with the St. Louis Gateway Area Chapter of Multiple Sclerosis. Keating says the diagnosis changed his life forever. Together they both have learned to adjust in different ways as MS affects what they can do .My first reaction was of denial and worry , what would my future be like?But my future has been very beautiful. I have two children I have raised and I continue my career as a nurse and wife.

Multiple sclerosis (MS) is a potentially debilitating disease in which your bodys immune system eats away at the protective sheath that covers your nerves. This interferes with the communication between your brain and the rest of your body. Ultimately, this may result in deterioration of the nerves themselves, a process thats not reversible.

Symptoms vary widely, depending on the amount of damage and which nerves are affected. People with severe cases of multiple sclerosis may lose the ability to walk or speak. Multiple sclerosis can be difficult to diagnose early in the course of the disease because symptoms often come and go sometimes disappearing for months.

Like anyone else in the MS movement, they actively volunteer and seek effective means to move closer to a world free of MS.

At this point theres no cure for multiple sclerosis. If you would like to join the movement with over 3,000 other cyclists riding towards a world free of MS, you can team up for the Bike MS Gateway Getaway Ride September 8&9 2012 in Columbia Missouri.

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Fighting Back -Ordinary People Battling The Everyday Effects Of MS

Gingko biloba does not improve cognition in multiple sclerosis patients, study finds

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ScienceDaily (Sep. 13, 2012) Many people with multiple sclerosis for years have taken the natural supplement Gingko biloba, believing it helps them with cognitive problems associated with the disease.

But the science now says otherwise. A new study published in the journal Neurology says Gingko biloba does not improve cognitive performance in people with multiple sclerosis. The research was published in the Sept. 5, 2012, issue of Neurology, the medical journal of the American Academy of Neurology. The current study was a more extensive look at the question after a smaller 2005 pilot study suggested there might have been some cognitive benefits in MS patients using the supplement. That study found that Gingko seemed to improve attention in MS patients with cognitive impairment.

But the larger follow-up study, conducted with patients at the Portland and Seattle Veterans Affairs medical centers, found no cognitive benefits to using Gingko.

"It's important for scientists to continue to analyze what might help people with cognitive issues relating to their MS," said Jesus Lovera, M.D., the study's lead author, a former fellow at the Portland VA Medical Center and former instructor in Oregon Health & Science University's Department of Neurology, where he did much of the work on the study. Lovera is now with the Department of Neurology at the Louisiana State University Health Sciences Center.

"We wanted to follow up on the earlier findings that suggested there may be some benefit. But we believe this larger study settles the question: Gingko simply doesn't improve cognitive performance with MS patients," said Lovera.

About one-half of people with MS will develop cognitive problems, and those cognitive problems can be debilitating in some people, said Dennis Bourdette, M.D., a co-author of the study, co-director of the VA MS Center of Excellence-West at the Portland VA Medical Center and chairman of the OHSU Department of Neurology. The most common problems relate to memory, attention and concentration, and information processing.

There is no known treatment that can improve cognition with MS patients -- which is partly why MS patients and researchers had hoped that Gingko biloba could help.

Lovera was also the lead author in the 2005 study, conducted at OHSU. That study included 39 participants who were given Gingko biloba or a placebo. The new study included 120 participants given Gingko or a placebo.

The study was supported by a grant from the U.S. Department of Veterans Affairs Rehabilitation Research and Development Service.

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Gingko biloba does not improve cognition in multiple sclerosis patients, study finds

/R E P E A T — A&W Rendez-vous to end MS: On Thursday, August 23, join Patricia Paquin and the Multiple Sclerosis …

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For each Teen BurgerTM sold in Canada , $1 will be given to the MS Society

MONTREAL , Aug. 20, 2012 /CNW Telbec/ - For a fourth consecutive year, the Multiple Sclerosis Society of Canada invites Quebecers to join the fight against MS as part of its annual fundraising and awareness event, in collaboration with A&W Food Services of Canada Inc. (AW-UN.TO).

How can I contribute?

Exclusively on Thursday, August 23 , for each Teen Burger sold across the country, one dollar will be donated to help fight MS. The A&W Rendez-vous event will also feature several fundraising activities in participating restaurants, including games, raffles, prizes and even personal appearances by the Great Root Bear himself! Well-known personality Patricia Paquin will be at the Plateau-Mont-Royal A&W restaurant, located at 4501 St-Denis Street, between 11:30 a.m. and 1 p.m.

Furthermore, until August 23:

"The A&W Rendez-vous to end MS campaign greatly contributes to financing ongoing MS cause and treatment research, as well as services offered to Canadians suffering from this illness, which is diagnosed in three Canadians per day, explains Yves Savoie, President and CEO, MS Society of Canada . We are very grateful toward all donors, as well as A&W guests and employees, for the active role they play year after year to ensure that this important fundraising event is a resounding success."

Canada posts one of the world's highest multiple sclerosis incidence rates. Indeed, an estimated one out of every two Canadians knows someone suffering from MS, and approximately 50,000 to 75,000 Canadians are currently fighting this disease. Of this figure, nearly 20,000 live in Qubec. While the cause of this often debilitating illness remains unknown, researchers are getting closer to a solution. The MS Society of Canada , the foremost organization in MS research, funds services to those suffering from MS and their families.

"In three years, A&W guests, employees and franchisees have raised over two million dollars to help fight MS, said Paul Hollands , President and CEO, A&W Food Services of Canada Inc. We're thrilled by this success and invite everyone to help make this incredible feat a reality by participating in the A&W Rendez-vous to end MS on August 23."

About multiple sclerosis and the MS Society of Canada Multiple sclerosis is a chronic, often disabling disease of the brain and spinal cord. It is the most common neurological disease of young adults in Canada . Most people with MS are diagnosed between the ages of 15 and 40, and the unpredictable effects of MS last for the rest of their lives. The MS Society provides services to people with MS and their families and funds research to find the cause and cure for this disease. Please visit mssociety.ca or call 1800 268-7582 to make a donation or for more information.

A&W Food Service of Canada Inc. is a purely Canadian company and one of the most recognized brands within the Canadian food service industry. A&W is the country's second largest hamburger restaurant chains, operating 730 locations across Canada . A&W restaurants offer their famous menu, which includes the Burger FamilyTM, Chubby ChickenTM and A&W Root BeerTM. For more information, please visit http://www.aw.ca.

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/R E P E A T -- A&W Rendez-vous to end MS: On Thursday, August 23, join Patricia Paquin and the Multiple Sclerosis ...

Multiple sclerosis breakthrough raises hope for improved therapies

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Multiple sclerosis is a prevalent disease that affects about 250,000 to 350,000 Americans, according to the National Institute of Health. This disease afflicts the brain and spinal cord, which make up the central nervous system, and causes the inflammation of the meninges, a lining of cells that cover the surface of the brain.

Though this is, as yet, an incurable disease, MS has many treatment and therapeutic options for patients. A group of Wayne State researchers, along with colleagues in Canada, have found a possible pathway that leads to disease progression which could lead to new therapies for patients.

WSU School of Medicine neurology associate chair and professor Joyce A. Benjamins, neurology professor Robert P. Lisak, neurology and immunology & microbiology assistant professor Samia Ragheba, neurology research assistants Liljana Nedelkoskaa and Jennifer Barger all contributed to the study.

The main idea behind the study was to see if B cells from patients with MS make substances that could be secreted that could damage CNS cells, Lisak said.

B cells are a type of lymphocytes, or white blood cells, that produce antibodies, which help the body in immune responses. In patients with multiple sclerosis, however, the B cells produce molecules that damage oligodendrocytes, which make myelin, Lisak said.

Myelin is a type of insulation for the axons of the nerve cells, neurons, in the CNS. If these protective coats are damaged and degraded, chemical communication between the brain and the rest of the body will be halted. Therefore, body movements such as walking, talking or bladder and bowel control are greatly hindered.

Benjamins said damage is not only done to the myelin sheath, but also to the neurons in a region of the brain called gray matter due to the dense population of neurons. Areas of gray matter are also called the cerebral cortex, and it is seen that damage in this area occurs early in the progression of the disease. The experiment to investigate B cells was conducted with the help of Canadian counterparts, Lisak said.

Our collaborators in Montreal isolated and cultured B cells from the blood of seven patients with MS and four healthy individuals, Lisak said.

The liquid from the cultures was sent to WSU where it was put in CNS culture. By analyzing the results, researchers found that the liquid from the B cells of MS patients killed oligodendrocytes, but not from the liquid of normal individuals.

This lead to the researchers conclusion that MS patients B cells secrete some sort of molecules or substances that directly attack CNS cells. These results are quite relevant and important for the study of progression. Lisak said these results show a new way through which B cells can damage neurons in MS; this novel pathway can lead the direction of how future therapies and treatment target the disease.

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Multiple sclerosis breakthrough raises hope for improved therapies