6 November 2020 - - British-Swedish pharmaceutical and biopharmaceutical company AstraZeneca's (OTC: AZNCF) 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 (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischemic attack.

The approval by the US Food and Drug Administration 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 ischemic 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.1 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. The results were in line with the known safety profile of Brilinta. Full data from the THALES Phase III trial can be found in The New England Journal of Medicine.

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.

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome and in more than 70 countries for the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack.

In May 2020, the US FDA approved a new indication for Brilinta to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.