Sanofi's tolebrutinib under FDA priority review for treating NrSPMS with positive results

From Nasdaq: 2025-03-25 02:23:00

Sanofi’s tolebrutinib is being evaluated by the FDA for treating non-relapsing secondary progressive multiple sclerosis, with a decision expected by September 28, 2025. If approved, it would be the first brain-penetrant BTK inhibitor for this condition. Tolebrutinib received breakthrough therapy designation based on positive results from the HERCULES phase 3 study. Clinical investigation is ongoing for primary progressive MS, with results expected in the second half of 2025. Regulatory submissions are also under review in the EU. Safety and efficacy have not been evaluated by any regulatory authority yet.



Read more at Nasdaq: Sanofi’s Tolebrutinib Under FDA Priority Review For Treating NrSPMS & Slowing Disability Progression