April 16th, 2015

Cangrelor Finally Gets Nod From FDA Advisory Panel

On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.

The news follows a decade of efforts to develop the drug — a potent, fast-acting, and reversible  antiplatelet agent. After the failure of two large clinical trials, the company finally achieved some success with its phase 3 CHAMPION PHOENIX trial two years ago. But last year the FDA raised questions about the trial and withheld approval until the company performed additional analyses.

The committee spent much of the day trying to determine a role for the drug in clinical practice, since it is now intended for use in ad hoc PCI, in which patients undergoing angiography are found to have obstructive coronary artery disease and undergo PCI in the same session. The data suggest that cangrelor may then be beneficial in patients who have not been pretreated with an oral P2Y12 inhibitor. A big problem, however, is that there is a very wide degree of variation in the use and acceptance of ad hoc PCI. The committee concluded that in the real world setting the benefits of cangrelor, though modest, outweighed the small increase in the risk of bleeding associated with the drug.

The FDA is expected to reach a final decision by June 23.


Comments are closed.