AstraZeneca Submits US New Drug Application for Brilinta (Ticagrelor), an Investigational Antiplatelet Agent
AstraZeneca today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA.
This submission is based on the results of a comprehensive programme, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase III head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix®) plus aspirin.
Acute coronary syndrome (ACS) is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle. These conditions range from unstable angina (chest pain) to myocardial infarction (heart attack). According to the American Heart Association, ACS affects an estimated 1.4 million people in the US every year. It is estimated that one in three ACS patients will die, have another heart attack or be hospitalised again within six months of the first cardiovascular event.
Ticagrelor is the first reversibly binding oral 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.
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About the PLATO study
PLATO was an international head-to-head outcomes study of ticagrelor versus clopidogrel to establish whether ticagrelor can achieve meaningful cardiovascular and safety endpoints in ACS patients. The phase III study investigated whether the inhibition of platelet aggregation seen with ticagrelor in phase II trials could lead to a reduction of cardiovascular events in the full spectrum of ACS patients, which includes patients hospitalized for unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
PLATO involved 18,624 ACS patients in 43 countries and was designed to provide a comprehensive analysis of efficacy, safety and tolerability of ticagrelor. The study design reflected real world clinical practice by enrolling the full spectrum of ACS patients within 24 hours of their index event, and evaluating their outcomes regardless of whether they were medically managed or underwent invasive procedures such as PCI or coronary artery bypass graft (CABG) surgery.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com