US FDA grants Priority Review for potential new indication for BRILINTA

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The FINANCIAL — AstraZeneca on April 29 announced that the US 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 enrolment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015, according to AstraZeneca.

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.

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 on 14 March 2015, and was also simultaneously published in the New England Journal of Medicine.

PEGASUS-TIMI 54 is part of AstraZeneca’s PARTHENON programme. The PLATO study, involving over 18,000 patients, was the first study in the programme and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are assessing 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.

 

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