US Food and Drug Administration Extends Review Timeline for Onglyza (Saxagliptin) New Drug Application

Thursday, 23 April 2009 AstraZeneca and Bristol-Myers Squibb reported today that the US Food and Drug Administration (FDA) has determined it needs additional time to complete the review of the New Drug Application (NDA) for ONGLYZA (saxagliptin) for the treatment of type 2 diabetes. Accordingly, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from 30 April 2009 to 30 July 2009. The NDA for ONGLYZA was submitted to the FDA on 30 June 2008. The companies continue to work closely with the FDA to support the review of ONGLYZA. ONGLYZA is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The ONGLYZA application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise, use in combination with three types of commonly used oral anti-diabetic (OAD) medications - metformin, thiazolidinediones and sulfonylureas (SUs) when the single agent alone does not provide adequate glycemic control, as an adjunct to diet and exercise – and use in initial combination therapy with metformin, as an adjunct to diet and exercise. NOTES TO EDITORS: Bristol-Myers Squibb and AstraZeneca Partnership Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes – ONGLYZA and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes. About AstraZeneca 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 About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com . ONGLYZA™ is a trademark of the Bristol-Myers Squibb Company CONTACTS: Media Enquiries UK: Neil McCrae +44 207 304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Media Enquiries US: Jim Minnick +1 302-886-5135 Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hard +44 207 304 5322 mob: +44 7789 654364 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: Z4-25396 Date of next review: August 2022 Resources All resources Open Innovation Externally sponsored scientific research Medical Information for HCPs US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement AZethics – Report A Concern Supplier information Social Media Community Guidelines Social Media LinkedIn Twitter YouTube Instagram Glassdoor Facebook utility links Legal notice and Terms of Use Privacy notice Site map Contact us Cookie policy © AstraZeneca 2021 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 ? ?

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