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BMS/AZ diabetes drug approved

Bristol-Myers Squibb and AstraZeneca have won US Food and Drug Administration approval for the type 2 diabetes drug Kombiglyze XR

Bristol-Myers Squibb (BMS) and AstraZeneca (AZ) have won US Food and Drug Administration (FDA) approval for the type 2 diabetes drug Kombiglyze XR, which will be the first marketed once-a-day metformin and dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet.

Kombiglyze XR is a combination of the DPP-4 inhibitor Onglyza (saxagliptin), which was discovered by BMS and is co-marketed with AZ, and extended-release metformin, which is the most commonly prescribed oral drug for diabetes. The combination product has been approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

The drug provides glycaemic control across glycosylated haemoglobin levels, fasting plasma glucose and post-prandial glucose, according to the companies. It is generally taken once daily with the evening meal.

The FDA approved the drug based on two phase III clinical trials of saxagliptin and immediate-release metformin as separate tablets compared to placebo plus immediate-release metformin, as well as studies demonstrating bioequivalence in healthy adults between Kombiglyze XR and saxagliptin plus metformin XR as separate tablets.

The combination therapy offers "a comprehensive mechanism of action that targets and addresses all three key defects in type 2 diabetes for improved glycaemic control: increases insulin secretion in a glucose-dependent manner, decreases hepatic glucose production, and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation," according to the companies.

The approval is the result of a collaboration entered into by BMS and AZ in early 2007 covering research, development and commercialisation of saxagliptin and dapagliflozin, a sodium-glucose cotransporter-2 inhibitor for diabetes. The partnership is global, excluding Japan, and may have other diabetes therapies added to it over time.

Under the deal, AZ made an upfront payment of $100m to BMS and agreed to make potential milestone payments of up to $650m. BMS said it made the deal as part of a larger strategy to concentrate its R&D efforts on serious diseases such as diabetes while maintaining commercial focus on specialists and high-prescribing primary care physicians.

8th November 2010


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