US FDA assigns new PDUFA date for BRILINTA (ticagrelor tablets)

Friday, 4 February 2011 AstraZeneca announced today that the US Food and Drug Administration (FDA) has acknowledged receipt of the company’s reply to the Complete Response Letter (CRL) for the ticagrelor New Drug Application (NDA). Accordingly, the agency has accepted AstraZeneca’s resubmission of the ticagrelor NDA, categorised it as a Class 2 resubmission to the CRL, and set a new PDUFA date of 20 July 2011. The FDA issued the CRL on 16 December 2010. On 21 January 2011, AstraZeneca announced it had submitted the requested supplementary analyses as part of its CRL response. AstraZeneca remains confident in the NDA submission for ticagrelor and will continue working with the FDA to progress towards completing the review of the NDA for ticagrelor. NOTES TO EDITORS About BRILINTA™ (ticagrelor tablets) BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA is the first reversibly-binding oral ADP receptor antagonist. BRILINTA is currently under regulatory review in 21 countries, including the US. The product has been approved in 30 countries, including in the EU, Iceland, and Norway, under the trade name BRILIQUE and in Brazil under the trade name BRILINTA. BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. 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 improve cardiovascular (CV) outcomes in ACS patients, compared to clopidogrel. The NDA submission for ticagrelor is based on the results of a comprehensive clinical trial programme, including data from the PLATO study. About PDUFA The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from companies that produce certain human drug and biological products, including when an NDA is submitted. It is usual for the FDA to set a PDUFA goal date when responding to an NDA. 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 $33.3 billion in 2010. For more information please visit: www.astrazeneca.com CONTACTS Media Enquiries UK Neil McCrae +44 20 7604 8236 (24 hours) Sarah Lindgreen +44 20 7604 8033 (24 hours) Abigail Baron +44 20 7604 8034 (24 hours) Media Enquiries US Emily Denney +1 302 885-3451 (US) Kate Childress +1 301 885 8217 mob: +1 302 290 7242 (US) Investor Enquiries UK Jonathan Hunt +44 20 7604 8122 mob: +44 7775 704032 Karl Hård +44 20 7604 8123 mob: +44 7789 654364 Nicklas Westerholm +44 20 7604 8124 mob: +44 7585 404950 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 Instagram utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2018 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 ↗