Sanofi’s tolebrutinib receives EU CHMP endorsement for specific multiple sclerosis patients despite US FDA setback

Sanofi's BTK inhibitor tolebrutinib is moving toward approval in the European Union for a subset of multiple sclerosis patients.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion, indicating that the drug meets the required benefit-risk profile for those patients.

The endorsement follows a complete response letter from the U.S. FDA in December, which means additional data or clarification are needed before U.S. approval.

If the CHMP recommendation is accepted by the European Commission, Sanofi could obtain a marketing authorization in Europe later this year, adding a new option for the targeted MS population.