Drug’s indication expanded to reduce heart attack, stroke risk

FDA cleared ticagrelor (Brilinta, AstraZeneca) to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD).

“This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV [cardiovascular] risk, but without a history of heart attack or stroke,” AstraZeneca said in a press release.

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Brilinta is already approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

Brilinta’s expanded indication was based on positive results from a Phase 3 trial. The study showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60 mg. versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke. 

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The Phase 3 trial, published in The New England Journal of Medicine and The Lancet, was multi-national trial of 19,000 patients with coronary artery disease and type 2 diabetes.

“Around one-third of patients with coronary artery disease have type 2 diabetes, putting them at higher risk of heart attack or stroke than patients without diabetes. Today’s approval brings new hope to patients at risk of experiencing a first heart attack or stroke,” said Gabriel Steg, MD, the trial’s co-chair and professor at Université de Paris.

AstraZeneca also recently announced the high-level results from the Phase III THALES trial, which showed aspirin plus Brilinta 90 mg. reduced the risk of the composite of stroke and death at 30 days after an acute ischemic stroke or transient ischemic attack, compared to aspirin alone.

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