Sanofi's Tolebrutinib Under FDA Priority Review For Treating NrSPMS & Slowing Disability Progression

(RTTNews) - Sanofi (SNY), a French pharmaceutical and healthcare company, announced Tuesday that the US Food and Drug Administration is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September 28, 2025. A regulatory submission is also under review in the European Union.

If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity, the company said.

Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES phase 3 study in adults with non-relapsing secondary progressive multiple sclerosis.

Sanofi noted that Tolebrutinib is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. The PERSEUS phase 3 study of tolebrutinib in patients with primary progressive multiple sclerosis is currently ongoing with study results anticipated in the second-half of 2025.

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