AstraZeneca: heart drug Brilinta granted FDA priority review

(CercleFinance.com) - The US Food and Drug Administration granted priority review to AstraZeneca's Brilinta for the reduction of subsequent strokes in high-risk patients, the Anglo-Swedish drugmaker said on Thursday.


The FDA has accepted a supplemental new drug application (sNDA) and granted priority review for Brilinta for the reduction of strokes in patients who have experienced an acute ischemic stroke or transient ischemic attack, the company said.

The FDA is set to make its final decision in the fourth quarter of 2020.

Results from a Phase III trial showed that aspirin plus Brilinta used twice daily for 30 days 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.

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