LONG BEACH, Calif. & BASEL, Switzerland– Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New Drug Application (NDA) for tapinarof for the treatment of plaque psoriasis in adult patients.
Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2022. The company submitted the NDA to the FDA on May 26, 2021.
Estimates suggest that psoriasis, a chronic and debilitating condition, impacts 8 million people in the United States and 125 million people worldwide. Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80–90% of people with psoriasis.
“With the FDA acceptance of our NDA for filing, Dermavant is one step closer to potentially providing a new option for adults with mild, moderate, and severe plaque psoriasis, who often deal with itch, pain, disfiguring appearance, and significant emotional and physical distress,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “The entire Dermavant team is now working diligently to prepare for the commercial launch of tapinarof, subject to FDA approval, and we look forward to further discussions with the FDA during the review process of this novel product candidate.”
The regulatory application is supported by positive Phase 3 data from PSOARING 1 and PSOARING 2, two replicate, multi-center, randomized, vehicle-controlled, double-blind studies, as well as the interim results from PSOARING 3, a 40-week, open-label safety study.
