FDA Grants Stroke Prevention Indication to Ticagrelor

The US Food and Drug Administration has granted an indication extension to ticagrelor (Brilinta; AstraZeneca) to include reducing the risk of stroke in patients with an acute ischemic stroke or high-risk transient ischemic attack, the drug’s manufacturer announced today. The agent is now approved as a 180-mg loading dose followed by a 30-day regimen of 90 mg, twice daily, for up to 30 days, to prevent recurrent neurological events.

The approval stems from the positive THALES trial results, first released back in January 2020 and subsequently published in the New England Journal of Medicine. THALES randomized 11,016 patients with minor acute ischemic stroke/TIA either to ticagrelor 180 mg on day 1 followed by ticagrelor 90 mg twice daily plus daily aspirin or to placebo plus aspirin. The primary efficacy endpoint of death and stroke at 30 days occurred in 5.5% of the ticagrelor/aspirin group as compared with 6.6% of the control group (HR 0.83; 95% CI 0.71-0.96; P = 0.02). The incidence of ischemic stroke, a secondary endpoint, was also significantly reduced in the active treatment arm.

The FDA had granted a priority-review designation for the stroke indication back in July, a week before the results were published. Ticagrelor is already FDA approved for the primary prevention of MI or stroke in adult patients with coronary artery disease at high risk for events, and for secondary prevention of cardiovascular events among patients with ACS or a history of MI.

Quoted in an AstraZeneca press release, Clay Johnston, MD, PhD (University of Texas, Austin), THALES’ lead investigator, called the announcement “much-awaited good news for physicians and patients.”

The good news is timely: while a number of recent studies like TICO and TWILIGHT have been carving out a role for an ticagrelor monotherapy instead of dual antiplatelet therapy after revascularization, others have challenged the drug’s superiority over its original comparator, clopidogrel, and when compared to another potent antiplatelet, prasugrel.