FDA approval is based on results of the phase III THALES trial, in which DAPT with ticagrelor and aspirin for 30 days reduced the rate of stroke and death by 17% vs aspirin alone.
The US Food and Drug Administration (FDA) today granted a label expansion for ticagrelor (Brilinta, AstraZeneca) to reduce the risk of recurrent stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA).
The approval, according to a press release from AstraZeneca, is based on positive results from the phase III THALES trial which found dual antiplatelet therapy with aspirin plus ticagrelor 90mg significantly reduced the rate of the composite of stroke and death vs aspirin alone in patient with acute ischemic stroke or TIA.
“One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days,” said S Claiborne Johnston, MD, PhD, principal investigator of the THALES trial and dean of the Dell Medical School at the University of Texas at Austin in the company press release. “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.”
The phase 3 THALES trial was conducted in more than 11 000 patients and demonstrated the ability of ticagrelor to reduce the rate of a primary composite endpoint of stroke and death by 17% (absolute risk reduction = 1.1%; HR, 0.83; 95% CI, 0.71-0.96; P=.015) when taken twice-daily with aspirin compared to aspirin alone in patients with an acute ischemic stroke or TIA. The primary composite endpoint was driven by a reduction in stroke.
Risk for severe bleeding events in patients receiving dual therapy was 0.5% and 0.1% in those receiving aspirin alone. There was no significant difference in incidence of disability between the 2 groups. Full data on THALES is available in the New England Journal of Medicine.
Ticagrelor is an oral, reversibly binding, direct-acting P2Y12 receptor antagonist that works by inhibiting platelet activation.
In May 2020, the FDA approved a new indication for ticagrelor to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease. The P2Y12 receptor antagonist, together with aspirin, is also approved for prevention of atherothrombotic events in adult patients with acute coronary syndrome and for secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack