FDA expands approval for AstraZeneca heart med

June 2, 2020

AstraZeneca’s Brilinta (ticagrelor) has been approved in the U.S. to reduce the risk of a first heart attack or stroke in high-risk patients with the most common type of heart disease coronary artery disease (CAD).

The approval by the U.S. Food and Drug Administration was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60mg versus aspirin alone in patients with CAD and type-2 diabetes (T2D) at high-risk of a first heart attack or stroke The primary composite endpoint was driven by a reduction in heart attack and stroke.

This is the first regulatory approval for aspirin plus Brilinta dual antiplatelet therapy in patients who have a high CV risk, but without a history of heart attack or stroke.

The trial demonstrated the relative risk reduction of the composite endpoint of heart attack, stroke and CV death by 10% with aspirin plus long-term Brilinta compared to aspirin alone in patients who had CAD and T2D without a history of heart attack or stroke. Regulatory submissions to expand the approved indication for Brilinta based on the trial are also under regulatory review in the EU, Japan and China.

Brilinta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS), and in more than 70 countries for the secondary prevention of CV events among high-risk patients who have experienced a prior myocardial infarction.

Read the AstraZeneca release