FDA grants priority review to AstraZeneca's filing for expanded use of Brilinta

AstraZeneca announced Wednesday that the FDA granted priority review to a marketing application for Brilinta (ticagrelor) for patients with a history of heart attack. The company indicated that the agency's target review date for the filing will be in the third quarter.

According to AstraZeneca, the submission is based on data from the PEGASUS-TIMI 54 study, which investigated Brilinta plus low-dose aspirin, compared to placebo plus low-dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior enrolment. Results from the trial, showing that Brilinta reduced the risk of a future cardiovascular event among heart attack survivors, were recently presented at the American College of Cardiology (ACC) annual scientific session and published in the NEJM.

Elisabeth Björk, head of cardiovascular and metabolic diseases, global medicines development at AstraZeneca, said "there is a clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction."

Brilinta is currently approved by the FDA to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS). The drug has also been authorised in Europe, where it is marketed under the name Brilique, for preventing atherothrombotic events in adults with ACS.

For related analysis, see ViewPoints: Soriot's Brilinta strategy earns its wings.

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