BMS, AstraZeneca plan to submit Onglyza for FDA approval

In light of favorable results from a Phase III study, Bristol-Myers Squibb and AstraZeneca have announced that they will submit an approval application to the Food and Drug Administration for their diabetes drug, Onglyza, which they developed in a collaboration that began last year.

A study of treatment-naive type 2 diabetes patients found that the drug, a DPP-4 inhibitor known generically as saxagliptin, improved control of glucose and reduced levels of glycosylated hemoglobin, also known as A1C.

The patients, who had A1C between 7 percent and 10 percent, took 2.5 mg, 5 mg and 10 mg doses of the drug. A1C decreased to less than 7 percent in 35 percent, 38 percent and 41 percent of patients, respectively. Twenty-four percent of patients taking placebo experienced similar reductions.

Onglyza was also found to reduce blood glucose after meals and after eight or more hours of fasting.