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Sanofi Nabs Priority Review For MS Drug Tolebrutinib

 
• By Kevin Grogan

A decision from the FDA is due by 28 September.

Priority Stamp
• Source: Shutterstock

Sanofi’s multiple sclerosis candidate tolebrutinib is in line for a potential US approval in the autumn after the Food and Drug Administration agreed to a speedy review of the oral Bruton’s tyrosine kinase (BTK) inhibitor.

 The regulatory agency is evaluating tolebrutinib under priority review for the treatment of non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adults. The target action date for the FDA’s decision is 28 September, Sanofi said, noting that a submission is also

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