Reported Saturday, Roivant's Priovant Therapeutics Wins FDA Priority Review For Brepocitinib After Phase 3 VALOR Trial Meets Primary And All Nine Key Secondary Endpoints In Dermatomyositis

Roivant's Priovant Therapeutics has received FDA Priority Review for brepocitinib following the successful Phase 3 VALOR trial, which met its primary and all nine key secondary endpoints in treating dermatomyositis. The trial demonstrated that brepocitinib 30 mg once-daily was superior to placebo, showing significant improvements in global disease activity, muscle strength, and skin disease. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application in the third quarter of 2026.