FDA priority review designation for AZ's Brilinta

AstraZeneca's heart drug Brilinta receives US FDA priority review designation


The US Food and Drug Administration (FDA) has accepted and granted Priority Review designation to AstraZeneca's Brilinta (ticagrelor) supplemental new drug application (sNDA) to treat 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 enrolment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015.

Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development, 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. Today's milestone reinforces the importance of investigating clinical questions that address unmet patient need and we look forward to working with the FDA as they review our submission."

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.


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