AstraZeneca Submits US New Drug Application For Ticagrelor (BRILINTA(TM)), An Investigational Antiplatelet Agent

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 26 Nov 2009 - 3:00 PST

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AstraZeneca (NYSE: AZN) announced it has submitted a New Drug Application (NDA) to the U.S. 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(TM), pending approval from the FDA.

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 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.(1) These conditions range from unstable angina (chest pain) to myocardial infarction (heart attack).(2) According to the American Heart Association, ACS affects an estimated 1.4 million people in the United States, every year.(3) It is estimated that one in three ACS patients will die, have another heart attack or be hospitalized again within six months of the first cardiovascular event.(4)

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.

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.

The PLATO results were presented at the European Society of Cardiology (ESC) annual meeting in August 2009 and simultaneously published in the New England Journal of Medicine.(5) The PLATO study design of was published in the April 2009 edition of the American Heart Journal.(6)

About Ticagrelor (BRILINTA(TM))

Ticagrelor (BRILINTA(TM)) is an investigational oral antiplatelet treatment for ACS and the first in a new chemical class, the CPTPs (cyclo-pentyl-triazolo-pyrimidines). Ticagrelor is chemically distinct from the thienopyridines, such as clopidogrel and prasugrel.

AstraZeneca has proposed the name BRILINTA.(TM) If approved by the FDA, it will serve as the trade name for ticagrelor. BRILINTA is a trademark of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.

References

(1) American Heart Association: Acute Coronary Syndromes. Paragraph 1, Lines 1 - 5

(2) American Heart Association: Antiplatelet Agents. Paragraph 2, Lines 1 - 2.

(3) American Heart Association: Acute Coronary Syndromes. Paragraph 3, Lines 3 - 5

(4) National Institute of Health: Heart Health - Heart Disease: Symptoms, Diagnosis and Treatment; What is Acute Coronary Syndrome. Paragraph 2, Line 1

(5) Lars Wallentin, M.D., Ph.D., Richard C. Becker, M.D., et al. Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes N Engl J Med 2009;361

(6) James S, Akerblom A, Cannon C et al, Comparison of ticagrelor, the first reversible oral P2Y12 receptor antagonist, with clopidogrel in patients with acute coronary syndromes: Rationale, design, and baseline characteristics of the PLATelet inhibition and patient Outcomes (PLATO) trial Am Heart J 2009;157:599-605

Source: AstraZeneca