A bid by AstraZeneca and Bristol-Myers Squibb to gain regulatory approval for the first of a new class of diabetes drugs has been dealt a setback. New data from the second of 10 planned late-stage studies for dapagliflozin demonstrated reduced blood sugar levels but an increased rate of infections among patients taking the drug. And analysts voiced concern that the data did not show any improvement in weight loss for patients in the drug arm.
The drug works by cutting excess glucose, one of a new class of SGLT2 inhibitors which are designed to block reabsorption of glucose. The companies have said that they could file for an approval as early as late next year. Some analysts have pegged potential sales in 2015 at $300 million.
Just three weeks ago researchers announced that dapagliflozin has registered promising results in a late-stage trial that combined the therapy with metformin, a standard therapy. Patients taking the combination therapy also lost more weight than a group that was given a combination of dapagliflozin and a placebo.
- here's the report from Reuters