FDA panel gives cangrelor a no-go

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 - Thumbs down, rejection

An FDA panel voted 7-2 against approval of The Medicines Company’s antiplatelet drug cangrelor for patients undergoing PCI.

The Cardiovascular and Renal Drugs Advisory Committee may have responded to concerns raised by one FDA official over the PHOENIX and CHAMPION clinical trials. CHAMPION PCI was stopped after it was determined it was not likely to meet its primary endpoint and CHAMPION PLATFORM also was ended early.

In neither trial did the drug demonstrate superiority over clopidogrel (Plavix, Sanofi-Aventis, Bristol-Myers Squibb) in reducing the composite of death, MI or ischemic revascularization 48 hours after PCI. Results also showed it was not superior over placebo for the combined endpoint of MI, all-cause mortality and revascularization. But data suggested benefits for stent thrombosis.

In CHAMPION PHOENIX, its use significantly reduced the rate of ischemic events, including stent thrombosis, during PCI.

The Medicines Company sought approval for cangrelor to reduce the risk of stent thrombosis and other thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI. It also proposed that cangrelor, an intravenous adenosine diphosphate–receptor antagonist, be prescribed to maintain P2Y12 inhibition in at-risk patients when oral P2Y12 therapy is interrupted due to surgery.

The FDA is expected to make a decision by April 30. The agency usually, but not always, follows the recommendation of its advisory panels.