The European Commission approved Sanofi’s drug Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without recent relapses. This authorization marks the first time the EU has approved a medicine specifically to target disability progression in this patient population.
Data from the HERCULES Phase 3 study showed the oral Bruton’s tyrosine kinase (BTK) inhibitor significantly delayed disability accumulation. While U.S. regulators rejected the drug in late 2025 over its benefit-risk profile, the European Medicines Agency endorsed its clinical benefits.
The EMA acknowledged potential liver-related side effects but determined the drug addresses a significant unmet medical need. Sanofi plans to launch Cenrifki in Germany before the end of the year.