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FDA Approve AstraZeneca's Brilinta To Reduce Risk Of Stroke In High-risk Patients With CAD

AstraZeneca Plc (AZN.L,AZN) said that the US Food and Drug Administration has approved the company's Brilinta or ticagrelor that will reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease or CAD, the most common type of heart disease.

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

Regulatory submissions to expand the approved indication for Brilinta based on the THEMIS trial are also under regulatory review in the EU, Japan and China.

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