If approved, dapagliflozin could be the first in a new class of insulin independent, oral type 2 diabetes agents to lower blood-sugar by increasing the amount of glucose excreted in the urine.
The results of a 24-week Phase III trial involving previously-untreated adults with type 2 diabetes who had high baseline blood-sugar levels revealed that dapagliflozin plus metformin XR significantly reduced blood-sugar levels compared to dapagliflozin or metformin XR alone plus placebo.
However, signs, symptoms and other reports suggestive of genital infections were more common in the dapagliflozin treatment groups.
A new drug application for dapagliflozin was accepted for review by the US Food and Drug Administration (FDA) in March 2011 with a Prescription Drug User Fee Act date set for 28 October 2011.
In addition, a marketing authorisation application was validated by the European Medicines Agency in January this year.
Dapagliflozin is the latest in a new line of diabetes drugs designed to lower blood-sugar levels, including Boehringer Ingelheim Pharmaceuticals and Eli Lilly’s Tradjenta, which was approved by the FDA in May.