FDA Advisory Committee rejects cangrelor for PCI - The Medicines Company
The Medicines Company announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted (7-2) to recommend against approval of the intravenous antiplatelet agent cangrelor for use in patients undergoing Percutaneous Coronary Intervention (PCI) -- or cardiac stent procedures -- or those that require bridging from oral antiplatelet therapy to surgery. The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) goal date for the cangrelor new drug application (NDA) is April 30, 2014.
The future of cangrelor in this indication is in doubt.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins