AstraZeneca Plc (AZN, AZN.L) said it submitted new drug application to the U.S. Food and Drug Administration for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome, or ACS. The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
The company noted that the submission is based on the results of a comprehensive program, including data from PLATO, the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel plus aspirin.
Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate, or 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.
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