AstraZeneca stroke drug gets US green light

AstraZeneca said the US Food and Drug Administration had accepted a supplemental new drug application and granted priority review for a drug used to reduce stroke in patients who experienced an acute ischemic stroke or transient ischemic attack.

The FDA action date for this supplemental application was scheduled for the fourth quarter of 2020.

The application was based on results from the Phase III Thales trial, which showed 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”, the pharma giant said on Thursday.

Stroke is the second leading cause of death worldwide, with 6.2m stroke-related deaths in 2017, of which 2.7m were due to ischaemic stroke, it added.