The European Commission approved Sanofi's drug Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without recent relapses. This marks the first EU authorization for a therapy specifically designed to target disability progression in this patient population.
Cenrifki is an oral Bruton's tyrosine kinase (BTK) inhibitor designed to penetrate the brain and address neuroinflammation. The HERCULES Phase 3 study demonstrated that the drug significantly delayed the onset of disability progression.
This approval follows a late 2025 rejection by the U.S. FDA. U.S. regulators cited concerns over the drug's risk-benefit profile and potential for liver injury.