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