Bristol-Myers Squibb Company and AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of Onglyza (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults. Bristol-Myers Squibb and AstraZeneca submitted the NDA with the US FDA for saxagliptin/metformin HCl extended-release tablets on December 29, 2009.

The NDA is based on bioequivalence data and data from the Onglyza phase 3 clinical trial programme which included studies for the co-administration of Onglyza and immediate release metformin, as an adjunct to diet and exercise, in adult patients with type 2 diabetes inadequately controlled on metformin alone and in treatment-naïve adult patients.

Onglyza has been submitted for regulatory review in more than 50 countries and is approved in 38 countries, including the United States and member states of the European Union. Onglyza approved by the FDA in July 2009 and is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus. Onglyza once daily can be used in combination with commonly prescribed oral anti-diabetic medications – metformin, sulfonylureas or thiazolidinediones (TZD) – or as a monotherapy to significantly reduce glycosylated hemoglobin (A1C) levels. Onglyza should Onglyza for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis (high levels of certain acids, known as ketones, in the blood or urine). Onglyza has not been studied in combination with insulin.

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines.