Sanofi: Regulatory Decision For Tolebrutinib To Be Delayed

(RTTNews) - Sanofi (SNY, SAN.PA) said it anticipates that the review process for the US regulatory review of tolebrutinib in non-relapsing secondary progressive multiple sclerosis will extend beyond the US target action date of December 28, 2025. The company 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.

Tolebrutinib is an investigational, oral, brain-penetrant Bruton's tyrosine kinase inhibitor specifically designed to target smoldering neuroinflammation, a key driver of disability progression in multiple sclerosis.

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