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

Sanofi announces that the US FDA has officially issued a complete response letter for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis in adult patients.

“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.

Note that Tolebrutinib was provisionally approved in the United Arab Emirates in July 2025 for the treatment of non-relapsing secondary progressive multiple sclerosis and to slow disability accumulation independent of relapse activity in adults.

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Related Topics and Keywords

multiple sclerosis, non-relapsing secondary progressive multiple sclerosis, phase 3 tolebrutinib, Sanofi, tolebrutinib