FDA Advisory Committee Backs Merck’s Vorapaxar

Merck’s anti-platelet drug vorapaxar has received backing from an FDA advisory committee who voted in favor of approving the drug for reducing atherothrombotic events in patients who have a history of myocardial infarction (MI). The Cardiovascular and Renal Drugs Advisory Committee of the FDA voted 10-1 in favor of approving the drug with the members stating that the benefits of the drug far outweighed the risks. The vote comes just after the release of FDA review documents which declared the drug to be effective in patients with history of MI.

The drug has been found to cause bleeding in some patients and the lone member of the committee who voted against the approval recommendation, Mori Krantz, said that apart from bleeding, he was also not sure how many patients will actually benefit from the drug.

“I voted No, not because I didn't think the primary efficacy was met, but I worried about the size of the benefit and, in particular, with endpoints that were harder, such as cardiovascular death, where we'd need to treat nearly a thousand patients to have one person benefit”, Krantz said.



Source-Medindia