FDA staff back approval of The Medicines Company's cangrelor

Staff at the US Food and Drug Administration have backed the approval of The Medicines Company’s (Nasdaq: MDCO) cangrelor to prevent blood clots during angioplasty, in briefing papers ahead of the Cardiovascular and Renal Drugs Advisory Committee scheduled for April 15.

This follows the FDA’s decision to decline approving the injectable investigational anticoagulant last year due to questions around the conduct of the CHAMPION PHOENIX trial. The Medicines Company has now resubmitted and FDA staff conclude that the trial was sufficient to warrant approval. The CHAMPION PHOENIX trial, a Phase III study, compared the safety and efficacy of cangrelor to Plavix (clopidogrel), from Sanofi (Euronext: SAN) and Bristol-Myers Squibb (NYSE: BMY) in more than 11,000 patients.

The trial showed that cangrelor reduced the combined risk of death, heart attack, repeat procedures and stent thrombosis by 22% against Plavix. The FDA determined that while the benefit of cangrelor compared to Plavix is small, the risk is also smaller.