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AbbVie's plaque psoriasis drug Humira gets marketing approval in Europe

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PBR Staff Writer Published 02 April 2015

The European Commission (EC) has granted marketing authorization for AbbVie's Humira (adalimumab) to treat children and adolescents with severe chronic plaque psoriasis.

The drug is indicated for use in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.

With the latest approval, Humira is now marketed for use in this indication in all member states of the European Union (EU).

The approval is based on the positive results of a Phase III trial, which will be reported at an upcoming medical meeting.

Currently, Humira has been approved in more than 87 countries and is being used to treat more than 851,083 patients worldwide.

AbbVie Research and Development executive vice president and chief scientific officer Michael Severino said: "With the approval from the European Commission, Humira is now the only biologic approved in Europe to treat children with this condition starting at four years of age, offering an important new option for physicians treating pediatric plaque psoriasis.

"This new indication contributes to the increasingly broad spectrum of indications for Humira, and supports its strong record of efficacy and safety in treating pediatric populations who are managing challenging chronic diseases."

Humira is indicated to treat severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease and moderate to severely active ulcerative colitis.

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AbbVie's plaque psoriasis drug Humira gets marketing approval in Europe

Psoriasis Healing Mentorship With Matt Ludwig – Win A Free Session! – Video

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Psoriasis Healing Mentorship With Matt Ludwig - Win A Free Session! - Video

AbbVie's HUMIRA (Adalimumab) Approved by European Commission to Treat Children and Adolescents with Severe Chronic …

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HUMIRA is the only Biologic Approved in Europe for Children and Adolescents from Four Years of Age with Severe Chronic Plaque Psoriasis

NORTH CHICAGO, Illinois, April 1, 2015 /PRNewswire/ --AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has granted marketing authorization for HUMIRA (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. With the EC decision, HUMIRA now has approval for use in this indication in all member states of the European Union.

"Several treatments have been shown to be effective in subgroups of patients with pediatric psoriasis. However, a limited body of supporting data is available. The approval of adalimumab is an important milestone in particular for children with severe disease because it extends the armamentarium of the physicians who are working to reduce the burden of this chronic disease in this sensitive young patient population," said Marieke M.B. Seyger, MD, PhD, Associate Professor of Dermatology, Radboud University Medical Center in Nijmegen, Netherlands.

The marketing authorization is based on the positive results of a Phase 3 study, which will be presented at an upcoming medical meeting. Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 851,083 patients worldwide1 across 11 globally approved indications.2

"With the approval from the European Commission, HUMIRA is now the only biologic approved in Europe to treat children with this condition starting at four years of age, offering an important new option for physicians treating pediatric plaque psoriasis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This new indication contributes to the increasingly broad spectrum of indications for HUMIRA, and supports its strong record of efficacy and safety in treating pediatric populations who are managing challenging chronic diseases."

About Pediatric Chronic Plaque PsoriasisAccording to estimates from the World Health Organization, pediatric psoriasis occurs in 0.70 percent of the pediatric population,3 with no significant difference by gender.4 The chronic autoimmune disease is characterized by the rapid and excessive accumulation of skin cells, which form thick patches of inflamed, scaly skin.5 Pediatric psoriasis has similar characteristics to adult psoriasis, but in children, the psoriatic lesions are typically smaller, thinner, and less scaly.4 Beyond the physical challenges of managing the chronic skin disorder, it is also considered to have significant emotional and psychological effects.6

HUMIRA EU Therapeutic Indications2HUMIRA is approved for use in moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's Disease and moderate to severely active ulcerative colitis.HUMIRA is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn's disease, and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy. See SmPC for full indication.

Important EU Safety Information2 HUMIRA is contraindicated in patients with active tuberculosis or other severe infections and in patients with moderate to severe heart failure. The use of HUMIRA increases the risk of developing serious infections which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with a TNF-antagonist. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache, abdominal pain, nausea, rash and musculoskeletal pain.

(see SmPC for full details at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124)

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit http://www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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How To Treat Eczema and Psoriasis Naturally VitaLife Show Episode 180 – Video

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How To Treat Eczema and Psoriasis Naturally VitaLife Show Episode 180
How To Treat Eczema and Psoriasis Naturally In this episode of the VitaLife Show, Dr. Janine Bowring, ND, expains the importance of treating eczema naturally from the inside out. She answers...

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How To Treat Eczema and Psoriasis Naturally VitaLife Show Episode 180 - Video

Are Psoriasis and Allergies Linked?

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If you have psoriasis and allergies, maybe you've wondered if your allergy flares make your skin condition worse.

There's no need to guess: Doctors and researchers haven't found links between the two problems. Here, four experts break down both conditions and explain what can trigger them.

Although psoriasis and allergies both involve your immune system, the causes for them aren't related.

Psoriasis is an autoimmune disease. That means your body's immune system wrongly attacks some of its own healthy cells.

An allergy happens when your immune system has a severe reaction to something that most people don't have a problem with, like pollen, pet dander, or certain foods.

Some people confuse psoriasis for allergies before they visit the doctor, because both conditions can cause itchy, red skin.

A lot of people come in thinking they have allergic skin problems and when I see them, they've got psoriasis, says Clifford Bassett, MD, an allergist and immunologist in New York City. "If you suspect it's one thing, it could be something else.

So, get checked by a dermatologist if your skin itches or flakes, he says.

If you have psoriasis, stress may be partly to blame when the disease first appears and when it flares. Stress can also make your allergies act up.

When you're having an allergic reaction, your body is working hard, says Julie Pena, MD, a dermatologist in private practice in Nashville. It's trying to fight something. When your body is going through stressful events, it alters the immune system. We know that stress can cause psoriasis to flare, [even] the internal stress of what your body is going through.

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Are Psoriasis and Allergies Linked?

Can-Fite BioPharma (CANF) Stock Plummets to 52-Week Low Today on Psiorasis Drug Trial Results

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NEW YORK (TheStreet) -- Shares ofCan-Fite BioPharma (CANF) plummeted more than 60% to a 52-week low of $2.16 on Monday announced that itsdrug candidate CF101 did not achieve its primary endpoint in aPhase II/III psoriasis trial.

The trial enrolled326 patients through 17 clinical centers in the U.S., Europe, and Israel. The company designed thestudy to test the efficacy of CF101 in patients with moderate-to-severe plaque psoriasis.

The primary efficacy endpoint was a statistically significant improvement in the Psoriasis Area Sensitivity Index (PASI) score relative to placebo treatment, and CF101 did not achieve this endpoint.

"We are disappointed that our trial did not meet its primary endpoint. Regretfully, in the PASI 75 and PGA we did not see any real effect in patients over placebo," said Can-Fite CEO Dr. Pnina Fishman in a statement. "We have not yet completed our analysis of secondary endpoint and sub-group analysis and intend to complete it in the near future. Can-Fite is continuing its research and development efforts in relation to its drugs and indications in the pipeline." CANF data by YCharts

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Can-Fite BioPharma (CANF) Stock Plummets to 52-Week Low Today on Psiorasis Drug Trial Results


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