Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreement

Sanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program.

The request follows a disagreement between acting Center for Drug Evaluation and Research director Tracy Beth Høeg and FDA staff who had recommended approval. The program, launched by FDA Commissioner Marty Makary, is intended to accelerate review of promising drugs.

Sanofi’s move highlights the regulatory challenges the drug faces and may delay its path to market, underscoring the importance of alignment within the agency for fast‑track designations.