EU Backs Sanofi MS Drug After US Rejection

Sanofi's multiple sclerosis treatment, tolebrutinib, has received a recommendation for approval from European regulators. The European Medicines Agency's human medicines committee endorsed marketing authorization for the drug, to be marketed as Cenrifki. This marks a significant step for the drugmaker, contrasting with its experience in the United States.

The US Food and Drug Administration declined to approve tolebrutinib late last year. The FDA cited concerns regarding potential liver injury, stating that the drug's risk-benefit profile was unfavorable even with proposed risk mitigation strategies. This decision was a setback for Sanofi, which had hoped tolebrutinib would become a blockbuster medication.

The company is actively seeking to diversify its revenue streams. This effort is partly driven by the looming patent cliff for its top-selling asthma drug, Dupixent. Sanofi's former CEO was replaced this year due to the pace of bringing new drugs to market.

Multiple sclerosis is a neurological condition affecting the brain and spinal cord. Sanofi's application targeted secondary progressive multiple sclerosis, a form characterized by a steady increase in disability. Few treatments are currently available for this specific type of MS.