FDA Flags Liver Injury Risk In Sanofi's Rejected Multiple Sclerosis Drug
01/06/2026 08:54 AM • 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.
SNY - 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.
Investing.com • David Wagner