Initial EU approval for Onglyza

Onglyza (saxagliptin) has received a CHMP positive opinion as add-on therapy to improve glycaemic control in adult patients with type 2 diabetes.

The decision was based on data from a comprehensive clinical development programme involving 4,148 patients that assessed the safety and efficacy of saxagliptin as a once-daily therapy.

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body’s ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver’s production of glucose.

The recommended indication is as an add-on therapy in combination with metformin,

Sulphonylurea or a thiazolidinedione, when these treatments alone do not provide adequate glycaemic control.

Manufacturers Bristol-Myers Squibb and AstraZeneca expect the European Commission to issue its decision on a marketing authorisation for this investigational drug in the coming months.