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AstraZeneca Applies To the FDA For Its New Angina and Heart Attack Treatment
AstraZenec (LSE: AZN) announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the drug ticagrelo. The application is for an investigational oral antiplatelet treatment for patients with acute coronary syndrome (ACS).
The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. According to AstraZeneca, Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The drug inhibits the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.
Acute coronary syndrome (ACS) is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle, including unstable angina and heart attacks. According to the American Heart Association (AHA), ACS affects an estimated 1.4 million people in the US every year. The AHA says that it is estimated that one third of ACS patients will have another episode within six months of the first cardiovascular event, often leading to hospitalisation, another heart attack or the patients death.
The submission to the FDA is based on the results of a comprehensive programme, it includes data from PLATO (A Study of Platelet Inhibition and Patient Outcomes) and the Phase III trial comparing ticagrelor plus aspirin with Sanofi Aventis’ Plavix®, clopidogrel plus aspirin.



















