FDA
16th April 2015

FDA Panel Recommends Approval of Cangrelor

Yesterday, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 – 2 with one abstention in support of approval of The Medicines Company’s investigational intravenous antiplatelet agent.

FDA Panel Recommends Approval of Cangrelor

Yesterday, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 – 2 with one abstention in support of approval of The Medicines Company’s investigational intravenous antiplatelet agent, cangrelor, an immediately bioavailable and quickly reversible intravenous P2Y12 platelet inhibitor. Cangrelor is intended to be used as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural thrombotic events such as myocardial infarction (MI), stent thrombosis (ST) and ischemia-driven revascularization. The materials for this meeting can be found HERE. Interestingly, cangrelor was reviewed by an FDA advisory committee panel last year, and did not receive a recommendation for approval with a vote of 7 to 2 as the panel felt the benefit/risk of cangrelor was not clear.

The vote was primarily based on the results of one randomized, double-blind clinical trial, CHAMPION PHOENIX, an 11,145 patient Phase 3 comparing cangrelor to oral clopidogrel in patients undergoing PCI.

Acting CRDAC chair, Dr. Philip Sager, Stanford University School of Medicine, CA, voted yes; noting, “a lot of good discussion.” Dr. Sager added that he was impressed the sponsor responded several times with additional data when asked.

Others on the panel voted in favor of approval, but not without hesitation. Dr. Stuart Rich, University of Chicago, noted, “I would have loved to have seen new data rather than the same data repackaged again and cherry-picked out. Certainly, I do not feel this was a vote of confidence. The only thing that persuaded me is that I know what goes on in day-to-day practice and the problems that come in. So I think some people will be helped.”

Loretta Itri, MD, Executive Vice President, Global Health Science and RegulatoryThe Medicines Company noted, “We are grateful for the recommendation of this Committee and appreciate the thorough review of our data for cangrelor,” and added said, “We look forward to continuing to work with the FDA in the coming weeks to bring this product to patients.”

In March 2015, the European Commission granted marketing authorization for cangrelor, which will be marketed under the trade name KENGREXAL™.The FDA is expected to complete its review of the cangrelor NDA by June 23, 2015.

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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