Johnson & Johnson has submitted an application to the FDA for the approval of Tremfya in psoriatic arthritis, which could further congest an intensely competitive therapy area.
Tremfya (guselkumab) is Janssens follow-up to IL-23/IL-12 inhibitor blockbuster Stelara (ustekinumab), which has faced competition from rival new treatments across immunology indications.
This includes Novartis Consentyx (secukinumab), AbbVies Skyrizi (risankizumab), Eli Lillys Taltz (ixekizumab) and Pfizers Xeljanz (tofacitinib citrate) , which are all already approved in psoriatic arthritis.
The application to the FDA is based on thetop line results from the pivotal phase 3 trials of Tremfya, DISCOVER-1 and DISCOVER-2.
The drug hit its primary endpoint of ACR20 response at week 24, and multiple secondary endpoints including ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA) and quality of life (SF-36 PCS and MCS).
DISCOVER-2 also assessed the effect on structural damage using the van der Heide-Sharp score as a key endpoint. DISCOVER-1 studied Tremfya in 381 participants, including some who were previously treated with anti-TNF biologics, and the duration of the study was 52 weeks. DISCOVER-2 included 739 biologic-naive participants, and continued up to 100 weeks.
J&J will face tough competition from other psoriasis therapies, including Novartis Cosentyx. The two drugs both treat psoriasis by targeting interleukins involved in the inflammatory process, with Consentyx targeting IL-17 and Tremfya inhibiting IL-23, and they are among a crowd of new biologic therapies vying for market share in the psoriasis category.
Despite the competition, Tremfya is still a source of growth for J&J sales of Tremfya, which came to market in 2017, totalled $452m over the first half of 2019. With a successfulhead-to-head trial against Novartis Cosentyx in plaque psoriasis under its belt, J&Js drug has been established as a significant contender in the crowded field of psoriasis drugs.
However, J&J has been subject to another head-to-head trial Eli Lillys Taltzoutperformed Tremfya in a post-marketing trial in patients plaque psoriasis.
Taltz already has a large portion of the market share, having generated sales of $606m over the first half of 2019, which suggests full-year revenues will beat the $938m it brought in last year.
Lillys Taltz has also been proved to be superior to market leader Humira (adalimumab), in reducing psoriatic arthritis activity by half, and also completely cleared patients skin after 24 weeks. These factors could damage Tremfyas uptake in this indication, if approved, but its already established presence in the field could counteract this.
AbbVies Humira and J&Js Stelara have remained blockbuster drugs, partly due to their ability to rapidly clear up 75% of lesions in most patients.
J&J is also set to submit a marketing application to the European Medicines Agency for Tremfya in the same indication before the end of the year.
Originally posted here:
J&J's Tremfya filed for approval in US for psoriatic arthritis - PMLiVE
- Why Jews With Psoriasis Might Think Twice About Seeking Treatment in Jordan - December 20th, 2013 [December 20th, 2013]
- Skin conditions leave emotional scars - December 20th, 2013 [December 20th, 2013]
- Psoriasis Free Forever Review | How This Program Helps People Treat The Root Causes Of Their Psoriasis Symptoms ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis | University of Maryland Medical Center - December 20th, 2013 [December 20th, 2013]
- Psoriasis Treatment, Symptoms, Pictures, Types, Prognosis ... - December 20th, 2013 [December 20th, 2013]
- Psoriasis - National Library of Medicine - PubMed Health - December 20th, 2013 [December 20th, 2013]
- Psoriasis: MedlinePlus - U.S. National Library of Medicine - December 20th, 2013 [December 20th, 2013]
- Psoriasis - Wikipedia, the free encyclopedia - December 20th, 2013 [December 20th, 2013]
- Psoriasis Symptoms, Treatment, Causes, Medication Information ... - December 21st, 2013 [December 21st, 2013]
- Psoriasis Free For Life Review - Watch This Before You Buy - Video - December 21st, 2013 [December 21st, 2013]
- Natural Psoriasis Relief in Seattle, Washington - Video - December 21st, 2013 [December 21st, 2013]
- PSORIASIS VULGARIS - Video - December 21st, 2013 [December 21st, 2013]
- Top 5 Powerful Home Remedies For Psoriasis - Video - December 21st, 2013 [December 21st, 2013]
- Psoriasis feedback after hijama - Video - December 21st, 2013 [December 21st, 2013]
- 9 Home Remedies For Scalp Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- Manga - Psoriasis - Video - December 22nd, 2013 [December 22nd, 2013]
- How to treat psoriasis | In Good Shape - Interview - Video - December 22nd, 2013 [December 22nd, 2013]
- Best Scalp Psoriasis Treatment - Video - December 22nd, 2013 [December 22nd, 2013]
- Sandoz begins Phase III clinical trial for biosimilar adalimumab - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis - Wikipedia, la enciclopedia libre - December 23rd, 2013 [December 23rd, 2013]
- What Is Psoriasis? - December 23rd, 2013 [December 23rd, 2013]
- Psoriasis Treatment Medical Course - Video - December 23rd, 2013 [December 23rd, 2013]
- Healing Psoriasis Hypnosis Session - Video - December 23rd, 2013 [December 23rd, 2013]
- Natural Farm cure for Skin Problems like Psoriasis - Video - December 26th, 2013 [December 26th, 2013]
- Psoriasis - 100% Natural Treatment Shivax® - December 27th, 2013 [December 27th, 2013]
- Psoriasis Symptoms, Causes, Treatment - What is psoriasis ... - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P3 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P2 - Video - December 28th, 2013 [December 28th, 2013]
- 79 PSORIASIS SYMPTOMS HOMEOPATHY TREATMENT K N SRIDHAR P1 - Video - December 28th, 2013 [December 28th, 2013]
- Can Acupuncture treat psoriasis and other scalp disorders? - Video - December 28th, 2013 [December 28th, 2013]
- Psoriasis - Wikipédia - December 31st, 2013 [December 31st, 2013]
- Psoriatic nails - Wikipedia, the free encyclopedia - December 31st, 2013 [December 31st, 2013]
- How to Cure Psoriasis - Psoriasis Symptoms, Treatment, Causes, Medication Information - Video - December 31st, 2013 [December 31st, 2013]
- Psoriasis Chronicles - Dealing with Depression, Anxiety and Anger - Video - January 2nd, 2014 [January 2nd, 2014]
- How to Prevent Psoriasis Flare-Ups - January 4th, 2014 [January 4th, 2014]
- Psoriasis Treatment | Health Plus | Studio N - Video - January 4th, 2014 [January 4th, 2014]
- Ayurvedic Remedy for Psoriasis - By Panditha Elchuri - Video - January 4th, 2014 [January 4th, 2014]
- Silica Gel For Psoriasis / Neurodermatitis - Video - January 4th, 2014 [January 4th, 2014]
- comment traiter son psoriasis détail oubliés - Video - January 4th, 2014 [January 4th, 2014]
- Psoriasis tends to relapse after stopping Methotrexate, shown in a case at Life Force - Video - January 4th, 2014 [January 4th, 2014]
- hiking nevada Health and Wellness Enthusiast Dawn Talks About Managing Plaque Psoriasis hiking watch - Video - January 5th, 2014 [January 5th, 2014]
- Guttate psoriasis - Wikipedia, the free encyclopedia - January 7th, 2014 [January 7th, 2014]
- Biofeedback May Help Control Stress-Related Diseases - January 8th, 2014 [January 8th, 2014]
- Psoriasis can be managed with proper treatment - January 10th, 2014 [January 10th, 2014]
- CNN anchor: How I fight psoriasis - January 10th, 2014 [January 10th, 2014]
- Psoriasis - My Home Remedies - January 10th, 2014 [January 10th, 2014]
- Psoriasis: MedlinePlus en español - January 10th, 2014 [January 10th, 2014]
- Psoriatic arthritis - Wikipedia, the free encyclopedia - January 10th, 2014 [January 10th, 2014]
- CNN anchor Zain Verjee: How I fight psoriasis - January 11th, 2014 [January 11th, 2014]
- Testimonio psoriasis - Video - January 14th, 2014 [January 14th, 2014]
- Heroin addict with severe Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- biospray for Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Psoriasis - Psoriasis Free For Life - Video - January 15th, 2014 [January 15th, 2014]
- 8 Cure For Scalp Psoriasis - Video - January 15th, 2014 [January 15th, 2014]
- Learn about plaque psoriasis, guttate psoriasis, inverse ... - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Symptoms, Triggers, and Causes of Psoriasis on WebMD - January 16th, 2014 [January 16th, 2014]
- Psoriasis Causes, Symptoms, Treatments, Home Remedies - January 16th, 2014 [January 16th, 2014]
- Psoriasis Treatment - Dermasis Psoriasis Cream - My Honest Review - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Psoriasis Speaks Couple Looking At Rings In Jewelery Store Emotional - Video - January 16th, 2014 [January 16th, 2014]
- TV Commercial Humira Psoriasis Medication Salon Clearer Skin is Possible - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis Symptoms, Causes and Treatment Pictures Slideshow - Video - January 16th, 2014 [January 16th, 2014]
- Psoriasis - Medscape Reference - January 19th, 2014 [January 19th, 2014]
- 5 Home Remedies For Scalp Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Ikonsulta Mo: Medical Advise on Psoriasis - Video - January 19th, 2014 [January 19th, 2014]
- Patient Recruitment: Television Campaign for Severe Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Patient Recruitment: Television Campaign for resistant, summertime Mild to Moderate Psoriasis - Video - January 23rd, 2014 [January 23rd, 2014]
- Dr stephen ferguson ND PhD chronic fatigue psoriasis cured - Video - January 23rd, 2014 [January 23rd, 2014]
- Noir Naturals Age of Innocence (Unscented) Goat's Milk Lotion for Psoriasis Relief - Video - January 23rd, 2014 [January 23rd, 2014]
- New biologic drugs offer relief for psoriasis sufferers - January 24th, 2014 [January 24th, 2014]
- Psoriasis traitement appliquer le lait pour le corps ISO UREA MD Vidéo La Roche Posay INFO PSO - Video - January 24th, 2014 [January 24th, 2014]
- Psoriasis - Video - January 24th, 2014 [January 24th, 2014]
- Coping with psoriasis - Video - January 26th, 2014 [January 26th, 2014]
- Exfoliative Dermatitis/Psoriasis Vulgaris with Psoriatic Arthritis with English Subtitles - Video - January 26th, 2014 [January 26th, 2014]
- Psoriasis skin care routine 2014 - Video - January 27th, 2014 [January 27th, 2014]
- How to treat psoriasis effectively - By Franziska Ringpfeil, Board Certified Dermatologist - Video - January 28th, 2014 [January 28th, 2014]
- My Psoriasis 411: Apple Cider Vinegar Tutorial for Scalp Treatment - Video - January 29th, 2014 [January 29th, 2014]
- 12 Best and Worst Foods for Psoriasis - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en radio Tagoror - Video - January 31st, 2014 [January 31st, 2014]
- Psocial Psoriasis en Canarias Hoy - Video - January 31st, 2014 [January 31st, 2014]
- Psoriasis Natural Treatment that Workswww savevid com - Video - January 31st, 2014 [January 31st, 2014]