Brilinta Granted FDA Priority Review for New Use

The FDA has granted priority review to expand the use of AstraZeneca’s ticagrelor (Brilinta) for the chronic secondary prevention of atherothrombotic events in patients with a heart attack history.

The supplemental New Drug Application for the blood thinner’s new indication was based on results from the large-scale PEGASUS-TIMI 54 trial, which compared ticagrelor plus aspirin with placebo plus aspirin in more than 21,000 patients who had experienced a heart attack 1 to 3 years prior to their enrollment.

The results demonstrated twice-daily doses of either ticagrelor 60 mg or 90 mg significantly reduced the risk of cardiovascular death, myocardial infarction, or stroke compared with placebo. However, ticagrelor treatment increased the risk of major bleeding.

“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,” said Elisabeth Björk, vice president and head of cardiovascular and metabolic diseases at the Global Medicines Development of AstraZeneca, in a press release.

Brilinta is an antiplatelet therapy currently approved in the United States to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome. It also reduces the rate of stent thrombosis in patients treated with percutaneous coronary intervention.