Sanofi Pulls Diabetes Drug From FDA Fast Track Program
Sanofi has requested to remove its diabetes drug Tzield from a priority FDA voucher program following internal agency disagreements over its safety profile. Regulators expressed concerns regarding potential links to Epstein-Barr virus and cancer despite Sanofi reporting no established causal relationship.
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SANOFI requested the U.S. Food and Drug Administration remove its diabetes drug Tzield from a fast-track review program following internal regulatory disputes. The move follows a disagreement between leadership and staff at the FDA over the drug's safety profile for younger patients. Investors face potential delays in Tzield's expansion as safety data comes under renewed scrutiny in the United States.
