FDA Accepts NDA for Dermavant’s Tapinarof

A decision on the plaque psoriasis therapy is expected in the second quarter of 2022.

Dermavant Sciences has announced that the FDA has accepted its new drug application (NDA) for tapinarof for the treatment of plaque psoriasis in adult patients.

Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent that has been developed as a once-daily, steroid-free topical cream for the treatment of plaque. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the second quarter of 2022.

“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,” Todd Zavodnick, chief executive officer of Dermavant, said in a statement.

The application is supported by positive phase 3 data from PSOARING 1 and PSOARING 2, two randomized, 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 the Physician Global Assessment (PGA) scores of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at week 12. About 40% of patients achieved complete disease clearance with continued therapy beyond 12 weeks.

Psoriasis is a systemic, chronic autoimmune skin disease that speeds up the growth cycle of skin cells, according to the Centers for Disease Control and Prevention, and more than 8 million people in the United States have psoriasis. Worldwide, about 125 million people—2% to 3% of the total population—have psoriasis, according to the World Psoriasis Day consortium. Plaque psoriasis is the most common form and affects about 80& to 90% of people with psoriasis.

Tapinarof is also being studied in phase 3 trials for atopic dermatitis.