Positive resutls from Phase III study of Forxiga (AstraZeneca/BMS) for Type 2 Diabetes patients

Results from a Phase III clinical study of Forxiga (dapagliflozin), from AstraZeneca and BMS, demonstrate significant reductions in blood sugar levels (glycosylated hemoglobin levels, or HbA1c) compared with placebo at 24 weeks when either agent was added to existing sitagliptin therapy (with or without metformin) in adult patients with Type 2 Diabetes. The results were maintained over a 24-week extension and similar results were observed when the data were stratified by background therapy. The study also demonstrated significant reductions in total body weight and fasting plasma glucose (FPG) levels in patients taking dapagliflozin added to sitagliptin (with or without metformin), with results maintained throughout the duration of the study extension. The findings were presented by Serge Jabbour, Division Director of Endocrinology, Thomas Jefferson University, at the 72nd American Diabetes Association (ADA) Scientific Sessions. In January 2012 the FDA issued a complete response letter regarding the New Drug Application (NDA) for Forxiga, requesting additional clinical data, and in April 2012, the CHMP issued a positive opinion recommending the approval of Forxiga for the treatment of Type 2 Diabetes.