November 19, 2009
NDA submitted for Brilinta for acute coronary syndromesAstraZeneca announced that it has submitted a New Drug Application (NDA) to the FDA for Brilinta (ticagrelor), an oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). 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 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix, from Bristol-Myers Squibb and sanofi-aventis) plus aspirin.
Brilinta is an orally active, reversible 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.
For more information call (800) 236-9933 or visit www.astrazeneca-us.com.