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AstraZeneca: FDA Accepts SNDA, Granted Priority Review For Brilinta To Treat Stroke

AstraZeneca (AZN.L,AZN) announced Thursday the US Food and Drug Administration has accepted a supplemental New Drug Application or sNDA and granted Priority Review for Brilinta (ticagrelor) for stroke. The Priority Review is for the reduction of subsequent stroke in patients who had an acute ischemic stroke or transient ischemic attack or TIA .

The company noted that Brilinta in combination with aspirin could be the first FDA-approved dual antiplatelet therapy to reduce the rate of stroke in these high-risk patients.

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the fourth quarter of 2020.

The sNDA was based on results from the Phase III THALES trial. Aspirin plus Brilinta 90mg used twice daily for 30 days in the trial resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone. The results were in line with the known safety profile of Brilinta.

The company will publish the data from the THALES trial in a peer reviewed journal and presented at an forthcoming medical congress.

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome or ACS. It is also approved in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.

In May 2020, the FDA approved a label update for Brilinta in the US to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

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