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FDA Delays Decision on New MS Therapy

By September 23, 2025eMS News

The FDA has extended its review of tolebrutinib, Sanofi’s investigational BTK inhibitor, with a new decision date of Dec. 28, 2025. Sanofi is seeking approval for tolebrutinib to treat non-relapsing secondary progressive MS (SPMS) and to slow disability accumulation in adults with MS, regardless of relapses.

The extension follows additional analyses submitted by Sanofi, which the FDA classified as a “major amendment.” Despite the delay, Sanofi remains confident in the therapy’s potential. Phase 3 data show tolebrutinib delayed disability progression by 31% in SPMS (HERCULES trial) and reduced disability worsening by 29% in relapsing MS compared with Aubagio (GEMINI studies). The therapy recently earned its first global approval in the UAE, and results from a trial in primary progressive MS are expected soon.

Many recent MS medications have also had similar three-month delays in final approval from the FDA, and this does not necessarily indicate any problem or issue with the drug itself.

For more information about tolebrutinib and BTK inhibitors, please see the following:

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