Press Release: Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis

Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis

Paris, December 24, 2025. The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients.

On December 15, 2025, Sanofi provided an update on the ongoing review which stated that: (i) FDA was expecting the review to go beyond the previously communicated revised US target action date of December 28, 2025; (ii) further guidance from the FDA was expected by the end of the first quarter of 2026; and (iii) in response to an FDA request, Sanofi had submitted an expanded access protocol for tolebrutinib in nrSPMS. The announcement was based on the latest discussions with the FDA, which took place just before the update was provided.

“Today’s FDA decision is a significant and meaningful change in direction from the feedback the agency previously provided to Sanofi. We are very disappointed by the FDA’s action. Disability progression remains a large unmet medical need in MS, and tolebrutinib was previously awarded breakthrough therapy designation by the FDA in recognition of its potential to address this critical gap. We believe that the FDA should also take the advice of scientific experts, clinicians, and patients in this matter to ensure all perspectives are considered. We remain committed to working with the FDA to find a path forward for tolebrutinib and ultimately serve the MS community,” said Houman Ashrafian, Executive Vice President, Head of Research & Development at Sanofi.

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