FDA investigating tolebrutinib under priority review

25 March 2025

The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission by French pharma major Sanofi (Euronext: SAN) 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, said Sanofi, whose shares edged up 1.5% on the news.

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