Tolebrutinib PDUFA Date (Sanofi)
FDA PDUFA decision date for Tolebrutinib is December 28, 2025. Developed by Sanofi. Indication: Non-relapsing secondary progressive MS (nrSPMS). Current status: CRL.
Indication
Non-relapsing secondary progressive MS (nrSPMS)
Regulatory details
- Company: Sanofi
- Therapeutic area: Neurology
- Application type: NDA
- Review type: Priority
- PDUFA date: 2025-12-28
- Outcome: CRL