Brilinta wins speedy US review in new indication

13 July 2020

Anglo-Swedish drugmaker AstraZeneca (LSE: AZN) has announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).

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

"A much-needed treatment option to reduce the rate of subsequent stroke for these patients and we look forward to working with the FDA to make Brilinta available as soon as possible"AstraZeneca's sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilinta 90mg 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. Results were in line with the known safety profile of Brilinta.

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