AstraZeneca’s Brilinta Approved for Patients with Coronary Artery Disease

The FDA has approved AstraZeneca’s Brilinta (ticagrelor) with aspirin to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

The approval was based on the results of a phase 3 trial that showed a statistically significant reduction in major adverse cardiovascular events at 36 months with aspirin plus 60 mg of Brilinta vs. aspirin alone.

The approval is the first for aspirin plus Brilinta in patients who have a high cardiovascular risk without a history of heart attack or stroke.