FDA Panel Rejects Sanofi (France) (SAN.PA) Clotting Drug for Chemo Patients
6/21/2012 7:14:53 AM
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.