Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischaemic stroke or high-risk transient ischaemic attack.- AstraZeneca

AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke or high-risk transient ischaemic attack (TIA). The approval by the FDA was based on positive results from the THALES Phase III trial that showed aspirin plus Brilinta 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischaemic stroke or TIA. The decision follows the Priority Review designation granted by the FDA in July 2020. The THALES trial demonstrated that Brilinta 90mg used twice daily and taken with daily aspirin for 30 days, reduced the rate of the primary composite endpoint of stroke and death by 17% (absolute risk reduction = 1.1%; hazard ratio 0.83; 95% confidence interval 0.71-0.96, p=0.015), compared to aspirin alone in patients with an acute ischemic stroke or TIA. This was a statistically significant and clinically meaningful reduction. The primary composite endpoint was driven by a reduction in stroke. The risk for severe bleeding events was 0.5% in patients receiving aspirin plus Brilinta and 0.1% for aspirin alone. Regulatory submissions to expand the approved indication are also under regulatory review in China and in the EU where the medicine’s name is Brilique..