Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tapinarof for the treatment of mild, moderate and severe plaque psoriasis in adult patients.
Tapinarof is a 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 a 60-day review period to determine whether the NDA is complete and acceptable for filing. The company submitted the NDA to the FDA on May 26, 2021.
“Psoriasis impacts approximately 8 million Americans, who have to navigate the physical and emotional toll from this devastating disease,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Today’s NDA submission marks a significant milestone as we work toward FDA approval of tapinarof for adults with plaque psoriasis and their dermatologists who are looking to fill current treatment gaps. We plan on continuing our commercial preparations to bring this novel product candidate to the U.S. market as expeditiously as possible, subject to regulatory approval.”
Today’s submission 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. In these studies, treatment with tapinarof cream led to statistically significant improvement relative to vehicle in Physician Global Assessment (PGA) scores of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at week 12, with statistically significant improvement in all secondary endpoints at week 12. Approximately 40% of patients achieved complete disease clearance with continued therapy beyond 12 weeks. In addition, a remittive benefit of approximately four months was observed following treatment discontinuation.