Home » AstraZeneca Gets Priority Review for Brilinta to Reduce Subsequent Strokes
AstraZeneca Gets Priority Review for Brilinta to Reduce Subsequent Strokes
Drugs Submissions and Approvals
The FDA granted priority review to AstraZeneca’s Brilinta (ticagrelor) with aspirin to reduce subsequent strokes in patients who have already experienced a first stroke.
The company’s supplemental new drug application (NDA) was based on the results of a phase 3 study in which aspirin plus Brilinta 90mg used twice daily for 30 days significantly reduced the risk of stroke and death compared to aspirin alone.
The agency approved Brilinta in May for reducing the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.