The FDA rebuffed The Medicines Company in its quest for approval of the antiplatelet agent cangrelor.
The agency sent a complete response letter to the Parsippany, N.J.-based company informing it was not approving the new drug application for cangrelor, an intravenous adenosine diphosphate-receptor antagonist. The Medicines Company applied for approval for cangrelor to reduce the risk of stent thrombosis and other thrombotic cardiovascular events in patients with coronary artery disease undergoing PCI; and to maintain P2Y12 inhibition in at-risk patients when oral P2Y12 therapy is interrupted for surgery.
In February, the Cardiovascular and Renal Drugs Advisory Committee voted 7-2 against approval. In its background material, the FDA raised concerns over the drug’s clinical trials. The trials failed to establish superiority over over clopidogrel (Plavix, Sanofi-Aventis, Bristol-Myers Squibb) or placebo for certain endpoints.
The Medicines Company said the FDA listed the need for additional clinical data, data analyses, review of data management processes and bioequivalence information among its comments. Clive Meanwell, chairman and CEO, said in a release that the company will focus on additional analyses.