AstraZeneca and Bristol-Myers Squibb today announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZA (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the programme.
The Advisory Committee unanimously recommended that the sponsors perform a post-marketing trial to confirm the cardiovascular profile of ONGLYZA. AstraZeneca and Bristol-Myers Squibb are working on a series of Phase IIIb and IV studies, including a large, controlled, randomised post-marketing trial, to further characterise the long-term clinical effectiveness as well as the cardiovascular profile of ONGLYZA. The companies will now work with the FDA to finalise the post-marketing trial design.
"We are encouraged by the Advisory Committee's recommendation and look forward to ongoing discussions with the FDA. AstraZeneca and Bristol-Myers Squibb are committed to delivering new therapeutic options that offer real benefits to patients and healthcare providers," said Howard Hutchinson, Chief Medical Officer, AstraZeneca.
ONGLYZA is an investigational, selective, reversible inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. 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.
The Advisory Committee based its recommendation on review of data from the comprehensive ONGLYZA clinical development program, which included more than 5,000 individuals, more than 4,000 of whom were given ONGLYZA. Data presented included safety and efficacy results from six pivotal Phase 3 trials, in addition to comprehensive post hoc pooled analyses evaluating cardiovascular risk in the Phase IIb and Phase III studies, which included individuals followed for up to 2.5 years and more than 3,700 person-years of exposure to ONGLYZA. The post hoc pooled analyses did not show evidence of a cardiovascular safety signal in individuals taking ONGLYZA.
The FDA is not bound by the Advisory Committee's recommendations, but takes its advice into consideration when reviewing new drug applications. Bristol-Myers Squibb and AstraZeneca will review the information leading to the Advisory Committee's decision and continue to work closely with the FDA to support the review of ONGLYZA. The new drug application for ONGLYZA was submitted to the FDA on 30 June 2008, and has an action date of 30 April 2009.
ONGLYZA, an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes, was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. ONGLYZA is being studied in ongoing and further planned clinical trials.
About DPP-4 Inhibitors
DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body's utilisation of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver's production of glucose.
Bristol-Myers Squibb and AstraZeneca partnership
Bristol-Myers Squibb and AstraZeneca entered into collaboration in January 2007 to enable the companies to research, develop and commercialise two investigational drugs for type 2 diabetes - saxagliptin 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.
ONGLYZATM is a trademark of the Bristol-Myers Squibb Company
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2 April 2009
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