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

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.

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.