FDA panel votes against approval of Medicines Co’s blood clot preventer
(Reuters) – An independent advisory panel to the U.S. Food and Drug Administration said a blood clot preventer developed by The Medicines Co should not be approved due to a lack of data to prove its efficacy. The panel voted 7-2 against approving the drug, cangrelor, for use during angioplasty — a heart surgery for widening narrow or clogged arteries. The panelists also voted unanimously against allowing cangrelor’s use in patients with stents, who are at an increased risk of events such as stent thrombosis — a blood clot that forms at the site of the stent. Panelists said they were not convinced that data from an 11,000-patient trial was enough to prove cangrelor’s efficacy, especially given the failure of two prior trials.