AstraZeneca and BMS submit MAA for Onglyza

AstraZeneca and Bristol-Myers Squibb (BMS) have submitted a marketing authorisation application (MAA) to the European Medicines Agency for Onglyza (saxagliptin) for the treatment of type 2 diabetes).

The companies have also made a new drug application to the US Food and Drug Administration for the compound in this indication.

Onglyza is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor currently being developed jointly by BMS and AstraZeneca.

Both companies entered into a collaboration to facilitate the research, development and commercialisation of saxagliptin and dapagliflozin in January 2007.

The regulatory submissions for the compound are based on comprehensive clinical trial programme data for the drug given in addition to traditional therapies and as a monotherapy in treatment-naive patients.

“The clinical trial program included studies that evaluated the drug at up to 80 times therapeutic clinical doses,” the company said.

It added that over 4,000 patients were involved in the six core phase III trials, with 3,000 of these individuals treated with saxagliptin.

In June 2008, BMS announced the results of a phase III study showing significant reductions in important measures of glucose control in treatment-naive type 2 diabetes patients administered with Onglyza.