FDA Panel Rejects Sanofi (France) Clotting Drug for Chemo Patients
Published: Jun 21, 2012
Sanofi (SAN) failed to win the backing of advisers to U.S. regulators for its drug to prevent blood clots in chemotherapy patients. Sanofi’s semuloparin doesn’t provide enough of a benefit to outweigh its risks, a Food and Drug Administration panel voted 14-1 today at a meeting in Silver Spring, Maryland. The advisers supported a June 18 FDA staff report that the Paris-based company’s data didn’t “provide meaningful support for the approval” as a treatment for venous thromboembolism among high- risk patients receiving chemotherapy for certain cancers.