15 December 2025 - Sanofi anticipates that the review process for the on-going US regulatory review of tolebrutinib in non-relapsing secondary progressive multiple sclerosis (nrSPMS) will extend beyond the previously communicated US target action date of 28 December 2025, and expects further guidance from the FDA by the end of the first quarter of 2026.

In response to an FDA request, Sanofi has submitted an expanded access protocol for tolebrutinib in nrSPMS, underscoring the company's commitment to providing eligible patients with access to this investigational therapy. Sanofi strongly believes in the risk-benefit profile of tolebrutinib for the treatment of nrSPMS.

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