FDA
14th February 2014

FDA Panel Votes Against Approval of Cangrelor

On Wednesday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommended against approval of the antiplatelet agent cangrelor for indications related to percutaneous coronary intervention and interrupted antiplatelet therapy.

FDA Panel Votes Against Approval of Cangrelor

On Wednesday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) recommended against approval of the antiplatelet agent cangrelor for indications related to percutaneous coronary intervention and interrupted antiplatelet therapy.

The vote was 2-7 against cangrelor for prevention of thrombotic events associated with coronary stenting. Additionally, in a vote of 0-9, committee members were unanimous in their belief that the evidence did not support a favorable recommendation for use of the drug in patients whose existing antiplatelet therapy is interrupted for surgery.

Cangrelor is a member of the P2Y12 inhibitor class of antiplatelet agents, which also includes clopidogrel (Plavix), prasugrel (Effient), and ticagrelor (Brilinta).

In the pivotal data under review, Parsippany, NJ-based The Medicines Co. tested cangrelor in more than 11,000 patients undergoing percutaneous coronary intervention, finding that its drug demonstrated a 22% reduction in risk of serious adverse events compared to Plavix. However, that study followed two other Phase III efforts in which the intravenous treatment failed to beat out the old pill, and The Medicines Co. briefly gave up on cangrelor before embarking on its latest late-stage effort.

In the background information provided in advance of the CRDAC meeting, the FDA’s Thomas Marciniak, MD, found the supporting clinical trial data unconvincing, and recommended against approval for both indications until flaws in the trials had been corrected to the FDA’s satisfaction.

In contrast, the FDA’s Fred Senatore, MD, PhD, found merit in the Medicines Company’s bid for approval of cangrelor to prevent thrombotic events and voted in favor of approval but was not satisfied with supporting information for the bridge indication and called on the company to address questions about the data in more detail.

“Against the background of two failed trials and with all of the issues at almost every aspect of the trials, starting from design, oversight, DSMB (data/safety monitoring board), how they counted efficacy, how they counted safety — it just left me with more uncertainty (and) I couldn’t defend the risk/benefit,” said committee member, Stuart Rich, MD, of the University of Chicago.

On the other hand, committee member, Milton Packer, MD, expressed some conflicted thoughts.

“I really wanted to vote Yes,” said Packer, of the University of Texas Southwestern Medical Center in Dallas. “The concept behind this drug was so intuitively appealing. The concept of an antiplatelet drug and the minute you turn it on, it works, and the minute you turn it off, it stops. To the extent that you want to inhibit platelets, that sounds really cool.”

However, Packer stated, the problem he had was that drugs should not be approved based on what they think they ought to do or based on surrogates.

In addition, Packer added, the company did a good job of relieving some of his discomfort, but so much discomfort remained about trial design, methods, and definitions that he could not recommend approval.

“Although we are disappointed by the committee’s decision, we appreciate the dialogue during today’s meeting and look forward to subsequent discussion with the FDA,” CEO sponsor, Clive Meanwell, said in a statement. “We continue to believe in the safety and efficacy of cangrelor and look forward to working with the agency as it completes its review.”

The FDA is not bound by CRDAC’s recommendation; however, they often abide by it.

Please click HERE to access the original meeting announcement for this product.

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