FDA to discuss MDCO's cangrelor
FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Feb. 12 to discuss an NDA from The Medicines Co. (NASDAQ:MDCO) for cangrelor to reduce thrombotic cardiovascular events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The company is also seeking approval for the IV antiplatelet therapy to maintain purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) inhibition in patients with acute coronary syndrome (ACS) or with stents who are at increased risk for thrombotic events when oral P2Y12 therapy is interrupted due to surgery.
The Medicines Co. expects a decision on the NDA in 2Q14; the specific date is not disclosed. An MAA for cangrelor is under review in Europe. The Medicines Co. has exclusive, worldwide rights to cangrelor, a reversible adenosine diphosphate (ADP) receptor (P2Y12) antagonist, from AstraZeneca plc (LSE:AZN; NYSE:AZN). ...