FDA Advisory Committee recommends US FDA approval of Brilinta (ticagrelor) for Acute Coronary Syndromes

Thursday, 29 July 2010 AstraZeneca 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). 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 ticagrelor could 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, 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. NOTES TO EDITORS: 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 ticagrelor could 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 commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com . CONTACTS: Media Enquiries: Neil McCrae +44 20 7304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Abigail Baron +44 20 7304 5034 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hård +44 207 304 5322 mob: +44 7789 654364 Clive Morris +44 207 304 5084 mob: +44 7710 031012 Investor Enquiries US: Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research MedImmune US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Facebook LinkedIn Twitter Glassdoor utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2019 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

The release as fetched from its publisher. astrazeneca.com ↗