Brepocitinib PDUFA Date (Roivant Sciences)
FDA PDUFA decision date for Brepocitinib is September 30, 2026. Developed by Roivant Sciences. Indication: Dermatomyositis. Current status: Approved.
Indication
Dermatomyositis
Notes
Dual TYK2/JAK1 inhibitor. Q3 2026 PDUFA — exact date TBD.
Regulatory details
- Company: Roivant Sciences
- Therapeutic area: Immunology / Dermatology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2026-09-30
- Outcome: Approved