US FDA has given the green-light to AstraZeneca's Brilinta - for fast track review

Pharmaceutical

AstraZeneca’s Brilinta (ticagrlor) for the reduction of subsequent stroke in patients who have experienced a transient ischaemic attack of ischaemic stroke has been given the green-light by the US Food and Drug Administration for a fast-tracked review.

The marketing application is based on evidence from the Phase 3 THALES trial, which found that 90 milligrammes of Brilinta used twice a day for thirty days, in addition to aspirin, resulted in a substantial and clinically relevant reduction in the risk of the primary composite outcome of death and stroke as opposed to aspirin alone.

“The US FDA has given the green-light to AstraZeneca's Brilinta, for fast track review.“

Some data from the trial has not yet been shared; however, AstraZeneca highlighted it will be presented at an upcoming medical congress and published in a peer reviewed journal.

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