AstraZeneca has submitted a NDA to the FDA for Brilinta, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
This submission is based on data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a Phase III trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin.
Brilinta is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists work to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.
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