AstraZeneca’s Brilinta gets FDA priority review for potential new indication

Brilinta is a direct-acting, selective and reversibly binding P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs) and it works by inhibiting platelet activation.

The sNDA is based on the data from large-scale outcomes Pegasus-TIMI 54 trial in more than 21,000 patients.

The trial 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 enrolment.

AstraZeneca vice-president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development Elisabeth Björk said: "Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event free after the first 12 months.

"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."

The company said that the Prescription Drug User Fee Act goal date will be in this third quarter.

The Pegasus TIMI-54 trial is part of the company’s Parthenon program, which involved the Plato study.

The first study in the program, Plato, included more than 18,000 patients and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines across the world.

Further ongoing Parthenon trials are evaluating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis.