FDA advisory committee votes against approval of antiplatelet therapy cangrelor

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted yesterday  against approval of the intravenous antiplatelet agent cangrelor made by US health care company The Medicines Company (Nasdaq: MDCO).

Trading of the company’s shares were halted for the meeting. Cangrelor was intended for use in patients undergoing percutaneous coronary intervention (PCI), otherwise known a 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 new drug application is April 30. It was reported that panel members were concerned about the design of the clinical trial comparing cangrelor to an older anti-clotting medicine and reports that cangrelor also had higher bleeding rates than the older therapy.