(RTTNews) - AstraZeneca (AZN.L, AZN) announced Thursday that its BRILINTA (ticagrelor), in the Phase III THALES Trial, significantly reduced the rate of the composite of stroke and death in patients who had an acute ischemic stroke or transient ischemic attack or TIA.
The detailed results from the positive trial showed 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%, compared to aspirin alone. The company said it was a statistically significant and clinically meaningful reduction.
Furthermore, aspirin plus BRILINTA significantly reduced the rate of the first secondary endpoint of ischemic stroke by 21%, compared to aspirin alone up to day 30. The results were in line with the known safety profile of BRILINTA.
The drug is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack.
The results from the THALES trial were published in The New England Journal of Medicine.
The US Food and Drug Administration last week accepted a supplemental New Drug Application or sNDA and granted Priority Review for Brilinta for stroke.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, "Patients who had an acute ischemic 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."
BRILINTA is indicated to reduce the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome or ACS.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.