Brilinta significantly reduced rate of composite of stroke and death in THALES trial

Detailed results from the positive Phase III THALES trial showed AstraZeneca’s Brilinta (ticagrelor) 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% (HR 0.83 [95% CI 0.71, 0.96], p=0.02), compared to aspirin alone in patients who had an acute ischemic stroke or transient ischemic attack (TIA).

This was a statistically significant and clinically meaningful reduction. Furthermore, aspirin plus Brilinta significantly reduced the rate of the first secondary endpoint of ischaemic stroke by 21%, compared to aspirin alone up to day 30.1 The risk for severe bleeding events was 0.5% in the aspirin plus Brilinta group and 0.1% in the aspirin group. The results were in line with the known safety profile of Brilinta.

Dr. Clay Johnston, lead investigator for the THALES trial and Dean of the Dell Medical School at The University of Texas in Austin, US, said: “About one in four stroke survivors go on to experience a second stroke, and the risk is particularly high within the first month after the initial event. Early treatment is important to prevent a subsequent stroke that may be disabling or fatal. It is also expected to improve long-term outcomes.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Patients who had an acute ischaemic stroke or transient ischemic attack may experience a subsequent, potentially avoidable stroke. Results from the Phase III THALES trial confirm that aspirin plus Brilinta has the potential to be a new effective treatment option for these high-risk patients and we look forward to continuing discussions with regulatory authorities.”

Results from the THALES trial were published in The New England Journal of Medicine.

This month, AstraZeneca announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or TIA based on the Phase III THALES trial. The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the fourth quarter of 2020.

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack. In May 2020, the FDA approved a label update for Brilinta in the US to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.