FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

The FDA has extended its review of Sanofi's oral multiple sclerosis drug, tolebrutinib, pushing the action date from September 28 to December 28, 20251357.

The delay follows Sanofi's submission of additional analyses to the NDA, which the FDA classified as a major amendment requiring additional review time137.

Tolebrutinib is an oral, brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor being reviewed for non-relapsing, secondary progressive multiple sclerosis (nrSPMS)135.

The efficacy of tolebrutinib is supported by phase 3 studies:
HERCULES (for nrSPMS) and GEMINI 1 and 2 (for relapsing MS)135.

If approved, tolebrutinib would be the first BTK inhibitor therapy available for nrSPMS, representing a new mechanism targeting central nervous system immune activity not directly targeted by current MS therapies35.

A separate phase 3 trial of tolebrutinib in primary progressive MS (PERSEUS) is ongoing, with results expected later in 202535.

Sources:

1. https://www.nasdaq.com/articles/fda-extends-review-period-sanofis-multiple-sclerosis-drug-filing

3. https://practicalneurology.com/news/fda-delays-decision-on-tolebrutinib-for-non-relapsing-secondary-progressive-ms/2483482/

5. https://www.neurologylive.com/view/fda-extends-review-time-for-sanofi-btk-inhibitor-tolebrutinib

7. https://www.empr.com/news/fda-extends-review-period-for-novel-ms-drug-tolebrutinib/