FDA calls for more info on The Medicines Company’s cangrelor

The US Food and Drug Administration has issued a Complete Response Letter for The Medicines Company’s (Nasdaq: MDCO) New Drug Application for its investigational intravenous antiplatelet agent cangrelor.

The CRL follows a recent negative vote against approval of the drug by an FDA advisory panel (The Pharma Letter February 13).

For the percutaneous coronary intervention (PCI) indication, the agency stated that the application cannot be approved at the present time. The FDA suggested that the company perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management, and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials.