Complete response for cangrelor
FDA issued a complete response letter for cangrelor from The Medicines Co. (NASDAQ:MDCO) for the two proposed indications for which the company was seeking approval: to reduce thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI); and as bridging therapy for patients with stents who are at increased risk for thrombotic events when oral P2Y12 therapy is interrupted due to surgery. FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approval of cangrelor for both proposed indications in February (see BioCentury Extra, Feb. 12).
According to The Medicines Co., FDA recommended that for the PCI indication, the company "perform a series of clinical data analyses" of the Phase III CHAMPION PHOENIX trial, review data management processes and provide bioequivalence information on the clinical supplies of clopidogrel. The Medicines Co. said FDA did not ask for an additional trial for the indication. The advisory committee members voted against approval for the indication in part due to concerns with the design of CHAMPION PHOENIX. ...