Credit: Kevin MacKenzie
The US Food and Drug Administration (FDA) has issued a Complete Response Letter to The Medicines Company regarding its new drug application for the antiplatelet agent cangrelor.
The company applied for approval of cangrelor to treat patients undergoing percutaneous coronary intervention (PCI) and those who require bridging from oral antiplatelet therapy to surgery.
The new drug application filing was based on the results of a development program that included 4 randomized trials.
These trials—BRIDGE, CHAMPION PHOENIX, CHAMPION PLATFORM, and CHAMPION PCI—included 25,567 patients with coronary artery disease.
In the Complete Response Letter, the FDA said it cannot approve cangrelor for the PCI indication without additional information.
The agency suggested The Medicines Company conduct 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 said a prospective, adequate, and well-controlled trial, in which outcomes such as bleeding are studied, is needed. Such a trial could provide the clinical data necessary to assess the benefit-risk relationship of cangrelor in this indication.
The FDA provided additional comments for the company to address, which could affect product labeling, but the company did not disclose them.
“We are grateful for the agency’s review, comments, and suggestions,” said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company. “The next steps of review will focus on additional analyses in response to the FDA.”
Cangrelor is an investigational agent not approved for commercial use in any market. The product is a bioavailable, quickly reversible, intravenous antiplatelet agent. It is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting.
