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News  ›  Benzinga

FDA Flags Liver Injury Risk In Sanofi's Rejected Multiple Sclerosis Drug

Benzinga Logo Benzinga By Vandana Singh
FDA Flags Liver Injury Risk In Sanofi's Rejected Multiple Sclerosis Drug

The FDA issued a complete response letter rejecting Sanofi's tolebrutinib drug application for non-relapsing secondary progressive multiple sclerosis due to serious safety concerns. The regulatory agency identified six cases meeting Hy's Law criteria for severe drug-induced liver injury (DILI) during clinical trials, including one death requiring liver transplant. The FDA determined that a favorable benefit-risk profile could not be established for any patient subpopulation, citing both efficacy and safety concerns.

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The FDA rejected Sanofi's drug application for tolebrutinib due to serious liver injury risks identified in clinical trials, including one patient death. This represents a significant setback for the company's multiple sclerosis treatment pipeline and eliminates a potential revenue opportunity for treating nrSPMS patients.