(Reuters) – AstraZeneca Plc said on Monday the U.S. Food and Drug Administration has approved its drug for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

The FDA approval was based on positive results from a late-stage trial of the drug, Brilinta, along with aspirin, which showed a statistically significant reduction in major adverse cardiovascular events, when compared to aspirin alone.

(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Vinay Dwivedi)