FDA advisory panel recommends approval of The Medicines Company's anticoagulant cangrelor

An FDA advisory committee on Wednesday voted 9-2 supporting the approval of The Medicines Company's anticoagulant cangrelor for use as an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural thrombotic events. Earlier this week, FDA staff also backed the approval of the drug for preventing blood clots during angioplasty. Executive vice president Loretta Itri remarked "we look forward to continuing to work with the FDA in the coming weeks to bring this product to patients."

The panel vote was based on data from the CHAMPION PHOENIX study comparing the injectable therapy to Sanofi and Bristol-Myers Squibb's Plavix. The FDA previously rejected cangrelor after agency staff raised questions regarding the conduct of the study.

The FDA is expected to issue a final decision on whether to approve cangrelor by June 23. Regulators in Europe cleared the therapy last month, which will be marketed under the name Kengrexal.

To read more Top Story articles, click here.