July 28th, 2010

FDA Cardiorenal Advisory Panel Recommends Ticagrelor Approval

The Cardiovascular and Renal Drugs Advisory Committee recommended today that ticagrelor (Brilinta, AstraZeneca) be approved for the treatment of STEMI and NSTEMI patients intended to be managed both invasively and medically. The committee spent most of the day trying to sort through the confusing finding in the pivotal PLATO trial that U.S. patients, unlike patients in the rest of the world, appeared to derive no benefit from ticagrelor compared with clopidogrel. The panel was skeptical of the explanation offered by the sponsor that higher doses of aspirin used in the U.S. could explain the discrepancy. In the end, the panel said the results could not be explained with existing data, and urged the FDA to include strong language about the finding in the product’s label and to require the sponsor to perform a clinical trial to further examine the issue.

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