November 6, 2020
AstraZeneca’s Brilinta Is Approved to Reduce the Risk of Stroke
November 6, 2020—AstraZeneca announced that Brilinta (ticagrelor) has been approved in the United States to reduce the risk of stroke in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤ 5) or high-risk transient ischemic attack (TIA).
According to the company, the FDA approval was based on positive results from the phase 3 THALES trial that showed aspirin plus Brilinta 90 mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA. In July 2020, the results of the THALES trial were published by lead investigator S. Clairborne Johnston, MD, et al in The New England Journal of Medicine (2020;383:207-217).
Dr. Johnston, who is Dean of the Dell Medical School at The University of Texas in Austin, Texas, commented in the company’s announcement, “One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days. The approval of Brilinta in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients.”
AstraZeneca reported that the THALES trial demonstrated that Brilinta 90 mg 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% CI, 0.71-0.96; P = .015), compared to aspirin alone in patients with an acute ischemic stroke or TIA. 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 versus 0.1% for aspirin alone.
The FDA approval follows the Priority Review designation granted by the FDA in July 2020. On June 1, AstraZeneca announced FDA approval of 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 (CAD).
In addition to the indication to reduce the risk of stroke in patients with acute ischemic stroke or high-risk TIA, Brilinta is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. It also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. It is also indicated to reduce the risk of a first MI or stroke in patients with CAD at high risk for such events.
Regulatory submissions to expand the approved indication are also under regulatory review in China and in the European Union where it is marketed as Brilique, advised AstraZeneca.