Sanofi (France): U.S. Probes Disclosures to FDA About Patient Response to Plavix
Published: Mar 11, 2013
The U.S. Justice Department is investigating disclosures to the Food and Drug Administration about the variability in patient responses to the blood-thinning drug Plavix, according to Sanofi (SNY), one of the drug's co-marketers. Sanofi became aware of the investigation in June 2012, but disclosed it for the first time in an annual report filed Thursday with the U.S. Securities and Exchange Commission. The French drug maker said it is cooperating with the Justice Department. Sanofi co-markets Plavix, which is used to stave off recurrent heart attacks and strokes, with New York-based Bristol-Myers Squibb Co. (BMY). The anti-clotting drug had worldwide sales of $9.3 billion in 2011, according to IMS Health, before it lost patent protection in 2012, which triggered competition from low-cost generics. Spokesmen for Sanofi and Bristol-Myers declined comment. A Justice Department spokesman couldn't immediately be reached. In 2010, the U.S. Food and Drug Administration added a boxed warning to the prescribing label for Plavix about the potential for reduced effectiveness in a subgroup of patients who metabolize the drug poorly.