Shots:
- The US FDA has accepted NDA & granted priority review to tolebrutinib for nrSPMS & slowing disability progression independent of relapse (PDUFA: Sep 28, 2025); MAA is under EMA review
- Submission was backed by P-III trials, incl. HERCULES for nrSPMS & GEMINI 1 & 2 for relapsing MS, along with clinical & preclinical data supporting tolebrutinib’s MoA while also aligning with the hypothesis that smoldering neuroinflammation is a key MS process & major driver of disability accumulation
- Additionally, Tolebrutinib is being evaluated in an ongoing P-III (PERSEUS) trial for primary progressive MS, with results anticipated in H2’25
Ref: Sanofi | Image: Sanofi
Related News:- Sanofi to Acquire Dren Bio’s Bispecific Antibody DR-0201 for ~$1.9B
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