New Drug Application for ticagrelor submitted to the FDA

AstraZeneca (NYSE: AZN) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA(TM), pending approval from the FDA.

This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix®) plus aspirin.

Acute coronary syndrome (ACS) is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle. These conditions range from unstable angina (chest pain) to myocardial infarction (heart attack). According to the American Heart Association, ACS affects an estimated 1.4 million people in the United States, every year. It is estimated that one in three ACS patients will die, have another heart attack or be hospitalized again within six months of the first cardiovascular event.

Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists inhibit the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.

SOURCE AstraZeneca