FDA accepts NDA for tapinarof cream
The FDA has accepted a New Drug Application for tapinarof cream for the treatment of plaque psoriasis in adults, Dermavant Sciences announced in a press release.
An investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, tapinarof is a once-daily, steroid-free in development for the treatment of plaque psoriasis and atopic dermatitis.
Data from PSOARING 1 and PSOARING 2, identically designed, randomized, vehicle-controlled, double-blind, parallel group studies, and PSOARING 3, a long-term, open-label extension study, were cited in the FDA’s decision.
All three phase 3 trials showed safety and efficacy of tapinarof cream 1% in adult psoriasis patients.
“To date in the psoriatic class, physicians and health care providers have only really had topical steroids to treat their patients. Then it moved on to oral medications and then to biologic injectables. There has never been a highly efficacious, nonsteroid preparation that has the ability to bring them potent efficacy, durability and potential remittance,” Todd Zavodnick, Dermavant CEO, told Healio. “We look forward to potentially bringing tapinarof to the market in mid-2022 and really being able to help patients for the first time to have an option to treat their mild-to-moderate psoriasis with a nonsteroidal, once-a-day, cosmetically elegant that has a target profile that is really unmatched in the market.”
A Prescription Drug User Fee Act (PDUFA) target action date has been set for May 2022. The company is also planning clinical trials of tapinarof cream for the treatment of atopic dermatitis, according to Zavodnick.