Priovant Therapeutics, a company backed by Pfizer (PFE) and Roivant Sciences (ROIV), announced on Tuesday that the U.S. FDA has granted priority review for its marketing application targeted at its lead asset, brepocitinib.
With its New Drug Application, the Durham, NC-based biotech seeks U.S. approval of brepocitinib as a treatment for dermatomyositis, a rare disease characterized by muscle weakness and skin rashes. The FDA has assigned a target action date in Q3 2026 for the NDA.
“We are committed to working closely with the FDA through their review to make this drug available for patients as quickly as possible,” Priovant CEO Ben Zimmer said.
The NDA is supported by data from the company’s 241-patient Phase 3 VALOR study, in which brepocitinib at 30 mg led to a statistically significant improvement in a clinical measure called the myositis Total Improvement Score, reaching the study’s main goal.
Priovant, which was established in 2021 as part of a transaction between Pfizer (PFE) and Roivant Sciences (ROIV), stated that if approved, brepocitinib will be the first FDA-approved targeted therapy for dermatomyositis.