US FDA grants priority review for new indication for AstraZeneca’s heart attack drug

The US Food and Drug Administration has accepted a supplemental new drug application (sNDA) and granted Priority Review for Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Brilinta (ticagrelor) tablets for patients with a history of heart attack.

A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015. In its current indications, Brilinta generated first-quarter 2015 sales of $131 million, up 32% year-on-year.

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 enrolment.