FDA approves Onglyza

AstraZeneca and Bristol-Myers Squibb (BMS) have received US Food and Drug Administration (FDA) approval for Onglyza (saxagliptin) for the treatment of type 2 diabetes mellitus in adults.

Onglyza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The once-daily dipeptidyl peptidase-4 (DPP-4) can be used in combination with commonly prescribed oral anti-diabetic medications, such as metformin, sulfonylureas and thiazolidinediones (TZDs), or as a monotherapy to significantly reduce glycosylated haemoglobin levels.

"Type 2 diabetes is a daily challenge for adults patients and physicians. With FDA approval of Onglyza, physicians and adult patients with type 2 diabetes have an important new treatment to help improve glycemic control," said David Brennan, AstraZeneca CEO.

DPP-4 affect the action of incretins; hormones that decrease elevated blood sugar levels by increasing the way the body uses sugar, mainly through increasing insulin production in the pancreas and by reducing the production of glucose in the liver.

The collaboration between AstraZeneca and BMS began in January 2007 with the aim of enabling the two companies to research, develop and commercialise select investigational drugs for type 2 diabetes.