Results from two 24-week phase-III studies presented at the 44th European Association for the Study of Diabetes Annual Meeting demonstrated that Onglyza (saxagliptin), an investigational selective inhibitor with extended binding to the dipeptidyl peptidase-4 (DPP-4) enzyme in development by Bristol-Myers Squibb Company and AstraZeneca, produced significant reductions across all key measures of glucose control studied [glycosylated haemoglobin level (A1C), fasting plasma glucose (FPG) and postprandial glucose (PPG)] when added to a sulfonylurea (SU) or a thiazolidinedione (TZD) in people with inadequately controlled type-2 diabetes, compared to placebo added to either an increased dose of SU or a stable dose of TZD. The addition of saxagliptin to SU or TZD was well tolerated over the course of the studies, and significantly more people were able to achieve target A1C of less than seven per cent versus the comparators.
The companies submitted a New Drug Application to the U S Food & Drug Administration (FDA) on June 30, which has been officially filed by the FDA, and a Marketing Authorization Application to the European Medicines Agency (EMEA) on July 1, which has been accepted for review by the Agency. The submissions are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The clinical trial programme included studies that evaluated the drug at up to 80 times the proposed usual clinical dose of 5 mg, once daily. 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. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
"A large number of people with type 2 diabetes have difficulty managing their disease, and remain uncontrolled," said Dr. Priscilla Hollander, Baylor University Medical Center, Director of Diabetes Programs, Dallas, Texas. "Given the growing number of people with diabetes around the world, it is important to investigate new therapeutic options as we fight this chronic disease."
Onglyza, the proposed trade name for saxagliptin, is an investigational DPP-4 inhibitor, under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes.
DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins.
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.