AstraZeneca (AZN) Submits US New Drug Application for Ticagrelor (BRILINTA(TM))

AstraZeneca (NYSE: AZN) 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.
AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services.