(RTTNews) - Pharmaceutical company AstraZeneca plc (AZN: News ,AZN.L: News ) said Thursday it has submitted a New Drug Application for ticagrelor to the U.S. Food and Drug Administration. Ticagrelor is an investigational oral antiplatelet treatment to reduce major adverse cardiac events in patients with acute coronary syndrome. The proposed trade name for ticagrelor is Brilinta, which is yet to be approved by the FDA.

The NDA filing was based on the results of data from an international head-to-head outcomes study involving 18,624 patients with adverse cardiac events, or ACS, in 43 countries, designed to provide a comprehensive analysis of efficacy, safety and tolerability of ticagrelor versus clopidogrel.

Earlier studies showed that ticagrelor achieved faster onset, greater inhibition of platelet aggregation, and faster offset in comparison to clopidogrel. Also, patients could be switched to ticagrelor without interruption of antiplatelet effect.

Studies show that ACS affects an estimated 1.4 million people in the US every year. sACS is a comprehensive term for conditions that result from a reduction in blood flow to the heart muscle, ranging from unstable angina or chest pain to myocardial infarction or heart attack.
Ticagrelor is an adenosine diphosphate receptor antagonist, the first reversibly binding oral P2Y12. Ticagrelor inhibits the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.

Clopidogrel is presently marketed as Plavix by Sanofi-Aventis (SNY: News ), as Clopilet by Sun Pharmaceuticals, as Ceruvin by Ranbaxy Laboratories, and as Clavix by Intas Pharmaceuticals. The market for anticlotting medicines is estimated at $9 billion. Sanofi-Aventis' blockbuster drug Plavix is the market leader, booking annual sales of EUR 2.62 billion in fiscal 2008.

AZN closed Wednesday's trading at $45.47, on the NYSE.

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by RTT Staff Writer

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