FDA accepts brepocitinib NDA for dermatomyositis, grants Priority Review; PDUFA Q3 2026

Roivant Sciences Ltd.

FDA accepted NDA and granted Priority Review for brepocitinib in dermatomyositis; PDUFA target action date in Q3 2026.
Launch expected at end of September 2026 if approved; supported by positive Phase 3 VALOR trial (N=241).
VALOR was first positive 52-week placebo-controlled study in dermatomyositis; brepocitinib 30mg met primary endpoint and all nine key secondary endpoints.
If approved, brepocitinib would be first targeted therapy for dermatomyositis; safety profile similar to approved JAK/TYK2 inhibitors.

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