Complete Response Letter from FDA for cangrelor for PCI and Coronary Artery Disease-The Medicines Company

The Medicines Company announced that the FDA has issued a Complete Response Letter for the Company's new drug application (NDA) for its investigational intravenous antiplatelet agent cangrelor. For the PCI indication, the Agency stated that the application cannot be approved at the present time. The Agency 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.

For the BRIDGE indication, the FDA has concluded that a prospective, adequate and well-controlled study in which outcomes such as bleeding are studied, can result in the clinical data necessary to assess the benefit-risk relationship in this indication.

The cangrelor NDA filing was based on the results of a development program which included the data from four randomized, double-blind clinical trials conducted in 25,567 patients with coronary artery disease (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE). The PHOENIX study provided the primary evidence of efficacy for the proposed PCI indication for cangrelor.