FDA staff support approval of The Medicines Company's anticoagulant cangrelor

Ahead of an FDA advisory committee meeting on April 15, agency staff on Monday backed the approval of The Medicines Company's investigational anticoagulant cangrelor for the prevention of blood clots during angioplasty. The regulator declined to approve the injectable therapy last year after reviewers questioned the conduct of the CHAMPION PHOENIX trial and asked the drugmaker to reanalyse data from the study. Following The Medicines Company's resubmission, FDA staff concluded that the "trial was sufficient to warrant approval of cangrelor."

The CHAMPION PHOENIX Phase III study compared the efficacy and safety of cangrelor to Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel) in more than 11 000 patients. Results from the trial illustrated that cangrelor reduced the combined risk of death, heart attack, repeat procedures and stent thrombosis by 22 percent versus Plavix.

"The benefit of cangrelor compared to [Plavix] is small, but the risk is smaller," FDA staff stated. In 2009, two late-stage studies of cangrelor in patients undergoing percutaneous coronary intervention were halted after The Medicines Company determined that the efficacy endpoints would not be achieved.

Analysts suggested that cangrelor, which if approved would be marketed in the US under the brand name Kengreal, has advantages over Plavix and other oral anticoagulants in that it rapidly induces an effect and leaves the system within an hour. RBC Capital Markets analyst Adnan Butt estimated that the therapy could amass between $100 million and $200 million in peak annual sales globally.

The European Commision recently granted marketing authorisation to the anticoagulant, which will be marketed in Europe under the brand name Kengrexal.

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