The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Brilinta (ticagrelor; AstraZeneca) for use in combination with aspirin, to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score less than or equal to 5) or high-risk transient ischemic attack (TIA).
The approval was based on data from the phase 3 THALES trial (N=11,016) that compared treatment with ticagrelor plus aspirin to aspirin alone in preventing new stroke events. Patients were randomized to receive ticagrelor 90mg twice daily or matching placebo, in addition to aspirin daily, within 24 hours of onset of acute ischemic stroke or high-risk TIA symptoms and were treated for 30 days.
Results showed that ticagrelor was superior to placebo in reducing the rate of the primary composite end point of stroke and death, with a relative risk reduction (RRR) of 17% (absolute risk reduction (ARR) 1.1%; hazard ratio [HR] 0.83; 95% CI, 0.71-0.96; P =.015). Moreover, ticagrelor demonstrated a significant reduction in the stroke component of the primary end point with a RRR of 19% (ARR 1.1%; HR 0.81; 95% CI, 0.69-0.95). In addition, ticagrelor met the secondary end point achieving a statistically significant risk reduction for the time to first ischemic stroke compared with placebo (HR 0.79; 95% CI, 0.68-0.93; P =.004).
The safety profile of ticagrelor was found to be similar to that seen in previous studies. The risk of severe bleeding events was reported to be 0.5% among patients receiving the combination treatment and 0.1% in those who received aspirin alone.
Dr. Clay Johnston, lead investigator for the THALES phase 3 trial and Dean of the Dell Medical School at The University of Texas in Austin, US, said: “One in 4 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.”
Brilinta, a P2Y12 platelet inhibitor, is already indicated to reduce the risk of cardiovascular death, MI, and stroke in patients with acute coronary syndrome (ACS) or a history of MI, and to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS. It is also approved to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events.
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- Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischemic stroke or high-risk transient ischemic attack. [press release]. Wilmington, DE: AstraZeneca; November 6, 2020.
- Brilinta [package insert]. Wilmington, DE: AstraZeneca; 2020.