Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that new data from the one-year safety and efficacy final analyses of the Phase 3 PSOARING 3 long-term, open-label extension ("LTE") study of VTAMAŽ (tapinarof) Cream, 1% for the treatment of plaque psoriasis in adults was published in the Journal of the American Academy of Dermatology (JAAD) on June 26, 2022.
"We are excited that a journal as prestigious as JAAD has chosen to publish final data from our PSOARING 3 40-week extension efficacy and safety study of VTAMAŽ (tapinarof) Cream, 1% for adults with plaque psoriasis," said Philip M. Brown, MD, JD, Chief Medical Officer of Dermavant. "We were delighted by the FDA's recent approval of VTAMA Cream for mild, moderate, and severe disease, which we believe can become an improved standard of care for plaque psoriasis patients and their healthcare providers. VTAMA Cream's demonstrated combination of efficacy, remittive effect, durability and tolerability make it a strong addition to the psoriasis armamentarium."
Newly published final data in JAAD includes efficacy outcomes, quality of life, safety, and tolerability assessments observed over long-term use of VTAMAŽ (tapinarof) Cream, 1%. The PSOARING 3 LTE study forms part of Dermavant's pivotal Phase 3 plaque psoriasis clinical program for VTAMA Cream. Treatment was based on Physician Global Assessment (PGA) score. Patients entering with PGA?1 received VTAMA Cream until reaching PGA=0. Efficacy outcomes in the additional 40-weeks of the LTE study illustrate continued improvement beyond the 12-week double blind treatment period in the pivotal studies (PSOARING 1 and 2) with up to 41% of patients (n=312/763) ultimately achieving complete disease clearance (PGA=0). In addition, once complete disease clearance was achieved in the LTE study and patients discontinued using VTAMA Cream (n=312), the mean total duration off therapy before disease worsening (defined as PGA?2) was 130 days. Patients with PGA?2 were re-treated with VTAMA Cream until reaching PGA=0. Importantly, there was no evidence of loss of effect while on therapy, illustrating a durable response. Lastly, there were no new safety or tolerability signals observed over long-term use, even in sensitive anatomic locations. The most frequent adverse events in the LTE study were folliculitis, contact dermatitis and upper respiratory tract infection.
On May 24, Dermavant announced that the FDA had approved VTAMA (tapinarof) Cream, 1% for the treatment of adult plaque psoriasis. The approval made VTAMA Cream the first topical novel chemical entity launched for psoriasis in the U.S. in twenty-five years. VTAMA Cream is approved for mild, moderate, and severe plaque psoriasis with no label restrictions on duration of use or body surface area.
IMPORTANT SAFETY INFORMATION
Indication: VTAMAŽ (tapinarof) Cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ? 1%) in subjects treated with VTAMA Cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.
Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.
Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant's focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company's robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
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