FDA Advisory Committee Recommends US FDA Approval of Brilinta (Ticagrelor) for Acute Coronary Syndromes

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Jul 28, 2010, 06:50 ET

WILMINGTON, Del., July 28 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended the FDA approve AstraZeneca's investigational drug ticagrelor for the reduction of thrombotic events in patients with Acute Coronary Syndromes (ACS).

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The Advisory Committee voted as follows:


Questions to the Advisory Committee	Yes	No	Abstain
1. Should ticagrelor be approved for reduction of thrombotic events in patients with nonST-elevation (NSTEMI) and ST-elevation (STEMI) ACS intended to be managed by PCI?	7	1	0
2. Should ticagrelor be approved for reduction of thrombotic events in patients with nonST-elevation (NSTEMI) and ST-elevation (STEMI) ACS intended to be managed medically?	7	1	0

The review by the Advisory Committee, part of the FDA's evaluation of the New Drug Application (NDA) submitted for ticagrelor, is based on the results of the large, head-to-head patient outcomes study PLATO (A Study of PLATelet Inhibition and Patient Outcomes). PLATO was designed to establish whether ticagrelorcould improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel. The study design reflected current clinical practice and included all major ACS patient types (STEMI and UA/NSTEMI), whether they underwent invasive procedures (PCI, coronary artery bypass graft surgery) or were medically managed.

"We are pleased with the Advisory Committee's recommendation to support the approval of ticagrelor. We look forward to continued discussions with the FDA as it evaluates the panel's recommendation and completes its review of the NDA," said Howard Hutchinson, M.D., Chief Medical Officer, AstraZeneca.

AstraZeneca filed the regulatory submission for ticagrelor, in the second half of 2009. The proposed trade name for ticagrelor in the US is BRILINTA™ (ticagrelor), pending approval from the FDA. Ticagrelor is also currently under regulatory review in nine territories around the world, including the European Union (EU), Canada, and Brazil.

The FDA frequently convenes advisory committee meetings to obtain independent expert guidance and recommendations on clinical matters. While the FDA is not required to follow this guidance, the agency takes the advice into consideration when rendering its final decisions on pending applications and other public health matters.

About ACS

ACS is an umbrella term for conditions that result from a reduction in blood flow to the heart muscle. These conditions range from UA (chest pain) to myocardial infarction (MI) (heart attack):

STEMI is a type of heart attack in which the coronary artery is generally blocked off by a blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to die.
UA/NSTEMI is a type of heart attack in which a blood clot partly occludes an artery and as a result only a portion of the heart muscle being supplied by the affected artery dies. UA is one of the types of ACS, a series of conditions most commonly produced by the rupture of a plaque in a coronary artery. UA is "unstable" not only because a plaque has potentially ruptured (a situation which threatens to progress to a myocardial infarction), but also because the symptoms it produces -- the angina -- generally occurs more frequently, often at rest, and lasts longer.

About the PLATO study

PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelorcould achieve clinically meaningful CV and safety end points in ACS patients, above and beyond those afforded by clopidogrel. PLATO was designed to reflect current clinical management of ACS patients and included and represented all types of ACS patients (STEMI, NSTEMI & UA) whether they underwent invasive procedures or were medically managed. As presented to the FDA Advisory Committee, ticagrelor demonstrated a reduction of CV events (CV death, MI, stroke) over clopidogrel (Plavix®/Iscover®) (9.8% vs. 11.7% at 12 months; 16% RRR; 95% CI, 0.77 to 0.92; p<0.001), without an increase in overall major bleeding (11.6% vs. 11.2%, p=0.43). Across the overall PLATO population, there was an 11% risk of major and minor bleeding.

About BRILINTA™/BRILIQUE™

Ticagrelor (BRILINTA/BRILIQUE) is an investigational oral antiplatelet treatment for ACS. Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization, of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology, and infectious disease medicines, AstraZeneca generated global revenues of $32.8 billion in 2009. In the United States, AstraZeneca is a $14.8 billion healthcare business.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

SOURCE AstraZeneca