News | April 30, 2015

FDA Grants Priority Review for Potential New Indication for Brilinta

Review based on PEGASUS-TIMI 54 study evaluating Brilinta for chornic secondary prevention of atherothrombotic events in heart attack patients

Brilinta, AstraZeneca, FDA, sNDA, PEGASUS-TIMI 54, new indication

April 30, 2015 — AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and granted Priority Review for Brilinta (ticagrelor) tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets 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 to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

The PEGASUS TIMI-54 study was presented during the opening late-breaking clinical trial session of the American College of Cardiology’s 64th Annual Scientific Session and Expo and was also simultaneously published in the New England Journal of Medicine online.

PEGASUS-TIMI 54 is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 patients, was the first study in the program. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischemic stroke or transient ischemic attack, and in patients with diabetes and coronary atherosclerosis.

Brilinta is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with peripheral arterial disease, stroke, diabetes or atherosclerosis.

Brilinta 90-mg tablets are indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with acute coronary syndrome (ACS), unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction [STEMI]). Brilinta has been shown to reduce the rate of a combined endpoint of CV death, myocardial infarction (MI) or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention (PCI), it also reduces the rate of stent thrombosis.

For more information: www.astrazeneca.com

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