First in Class Drug, Dapagliflozin (SGLT inhibitor) Expected for FDA Submission Soon

Last week, Bristol-Myers Squibb Co. announced that its diabetes drug dapagliflozin, in combination with metformin, significantly reduced levels of glycosylated hemoglobin in Type 2 diabetes patients as compared to placebo plus metformin in a late-stage study.

The study enrolled 546 patients aged between 18 and 77.

Bristol-Myers is co-developing dapagliflozin as a once-daily treatment for Type 2 diabetes with AstraZeneca.

Dapagliflozin, a member of a class of drugs known as SGLT2 inhibitors, is intended to treat Type 2 diabetes by helping the kidneys eliminate surplus glucose. The results from the 24-week trial, which were presented at the European Association for the Study of Diabetes (EASD) meeting in Vienna , also revealed that patients who took dapagliflozin had lower blood sugar levels when they were fasting. Furthermore, patients who took dapagliflozin and metformin lost more weight than patients taking metformin and placebo.

The two companies aim to file for approval of the candidate, which has blockbuster potential, in late 2010 or early 2011.