Briefing Summary: US FDA Posts Advisory Committee Materials for The Medicine Company’s Cangrelor, a Drug to Reduce CV Events in PCI Patients –April 15, 2015 (CRDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, April 15, 2015 Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Meeting. The Committee will discuss the new drug application (NDA) 204958 for cangrelor injection, submitted by The Medicines Company (MDCO), 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) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.