In the first Phase III study of Bristol-Myers Squibb and AstraZeneca's diabetes drug, dapagliflozin met both primary and secondary endpoints. When used with the common diabetes drug metformin, the drug reduced blood glucose levels and fasting plasma glucose in patients with type 2 diabetes inadequately controlled with metformin.
Dapagliflozin is part of a new class of drugs called SGLT2 inhibitors. The protein SGLT2 helps the body retain glucose for its energy requirements. But for patients with diabetes, glucose retention leads to persistent high blood sugar. SGLT2 inhibitors suppress this protein so that excess glucose is excreted from the body rather than reabsorbed.
Analysts project dapagliflozin sales at $1.5 billion, though they will keep an eye on potential safety issues with the drug. "Dapa's (dapagliflozin's) unprecedented efficacy offering for an oral anti-diabetic agent--with what we see as a manageable safety profile--puts it on a trajectory to be a risk-adjusted global blockbuster," UBS said in a research note, as quoted by Reuters. Barring any problems, approval is anticipated in 2010 or early 2011.
- here's the release
- see the Reuters report for more