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Dapagliflozin meets endpoints (NYSE:BMY)

Submitted by Jyotsna Ramani on October 5, 2009 – 7:00 amNo Comment

It was announced today that Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca’s diabetes drug dapagliflozin has successfully met the endpoints in the first phase III study. The companies together stated that their diabetes drug was able to meet both primary and secondary endpoints in the first phase trial successfully. The result from the 24 weeks clinical study has clearly demonstrated that dapagliflozin when added with metformin can reduce the blood glucose levels and fasting plasma glucose in type 2 diabetes patients. Dapagliflozin can significantly reduce primary endpoint (HbA1c) and secondary endpoint (FPG) that metformin cannot control alone.

Both the companies have further said that Dapagliflozin is a new class of drugs called SGLT2 inhibitors which is currently in trial stages. It is an investigational compound and once-a-day oral therapy for the treatment of type 2 diabetes. The aim of these SGLT2 inhibitors is to facilitate the elimination of glucose by the kidney which will help in returning serum glucose level to normal. The trial by Bristol-Myers Squibb and AstraZeneca was to access the efficacy and safety of dapagliflozin as an add-on to metformin. Though the study was only for 24 weeks, the extension phase of the study is for the total duration of two years.

Analysts speculate that the sales of dapagliflozin might be around US$1.5 billion as there are many patients in the United States who are suffering from diabetes and will go for dapagliflozin to treat their diabetes. It was in 2007 when Bristol-Myers Squibb and AstraZeneca (NYSE:AZN) entered into collaboration for the development and commercialization of investigational drugs for type 2 diabetes and they have finally come out with dapagliflozin as their successful medication for those who are suffering from type 2 diabetes. However, there are many other factors that are needed to be considered and therefore approval is anticipated in 2010 or early 2011.

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