OnglyzaTreatment for Diabetes Type 2
Update: Onglyza Now FDA Approved - July 31, 2009
New Drug Application Submission for Onglyza
Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes
PRINCETON, N.J. & LONDON--(BUSINESS WIRE)--July 23, 2008--Bristol-Myers Squibb Company and AstraZeneca today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30th and validation of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Onglyza (saxagliptin). Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. The companies have proposed the name Onglyza which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
The NDA and MAA submissions for saxagliptin are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naive patients as a monotherapy. The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses. The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin.
Onglyza, a DPP-4 inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. Saxagliptin is being studied in clinical trials as a once-daily therapy to determine its efficacy and safety. Saxagliptin was specifically designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Phase III data for saxagliptin have previously been presented in combination with metformin, the most commonly prescribed oral anti-diabetic, as well as when used as monotherapy in treatment-naive individuals. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.
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 utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver's production of glucose.
About Type 2 Diabetes
Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.
Bristol-Myers Squibb and AstraZeneca Collaboration
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 - 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.
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.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com
Onglyza (saxagliptin) is a trademark of the Bristol-Myers Squibb Company
CONTACT: Media: Bristol-Myers Squibb David M. Rosen, 609-252-5675 firstname.lastname@example.org or AstraZeneca Jim Minnick, 302-866-5135 email@example.com or Investors: Bristol-Myers Squibb John Elicker, 212-546-3775 firstname.lastname@example.org or AstraZeneca Mina Blair, 44-20-7304-5084 email@example.com SOURCE: Bristol-Myers Squibb Company
Posted: July 2008
- FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes - July 31, 2009
- U.S. Food and Drug Administration Extends Review Timeline for Onglyza (saxagliptin) New Drug Application - April 23, 2009
- Onglyza (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee - April 2, 2009