Background Analysis: US FDA Advisory Committee to Review The Medicine Company’s Cangrelor a Second Time – APR 15, 2015 (CRDAC)
The US FDA has scheduled a Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting for Wednesday, April 15, 2015. The Committee will discuss the new drug application (NDA) 204958 for cangrelor injection, submitted by The Medicines Company for the proposed indication of the reduction of thrombotic cardiovascular (CV) events, including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention. PCI refers to the opening of narrowed blood vessels supplying the heart muscle by a balloon inserted through an artery puncture with or without a stent.