FDA Approves Expanded Indication of Ticagrelor for Secondary Stroke Prevention

The Food and Drug Administration (FDA) has approved an expanded indication for ticagrelor (Brilinta; AstraZeneca, Wilmington, DE) for secondary stroke prevention. Ticagrleor is now approved for secondary stroke prevention in individuals who have had acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA).

FDA approval was based on results from the THALES phase 3 trial (NCT03354429) that showed aspirin plus ticagrelor 90 mg reduced the composite rate of stroke and death by 17% (hazard ratio [HR], 0.83; 95% CI, .71-.96; P=.015) compared with aspirin treatment alone in individuals who had experienced high-risk transient ischemic attack. The primary composite endpoint was driven by a reduction in stroke.

Dr. Clay Johnston, lead investigator for the THALES phase 2 trial and Dean of the Dell Medical School at The University of Texas in Austin, US, said: “1 in 4 patients who have had a stroke will experience a second, 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.”

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “In the US, someone has a stroke every 40 seconds and the impact on a person’s life can be truly devastating. Brilinta is a well-established medicine across patients with coronary artery disease and with today’s approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.”

The risk for severe bleeding events was 0.5% in participants receiving aspirin plus ticagrelor and 0.1% for aspirin alone. The results were in line with the known safety profile of ticagrelor. Full data from the THALES phase 3 trial were published in The New England Journal of Medicine.