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AstraZeneca, Bristol-Myers Squibb Receive FDA Approval For Onglyza

Onglyza to be used as an adjunct to diet and exercise to improve blood sugar control

AstraZeneca and Bristol-Myers Squibb have reported that FDA has approved 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 (glycemic) control in adults with type 2 diabetes mellitus.

Onglyza once daily can be used in combination with commonly prescribed oral anti-diabetic medications – such as metformin, sulfonylureas (SUs) or thiazolidinediones (TZDs) – or as a monotherapy to reduce glycosylated hemoglobin (A1C) levels. The dose of Onglyza is 2.5mg or 5mg once daily, regardless of meals, said the company.

David Brennan, CEO of AstraZeneca, said: “With the FDA approval of Onglyza, physicians and adult patients with type 2 diabetes have an important new treatment to help improve glycemic control.

“Onglyza is the product of a major collaboration between AstraZeneca and Bristol-Myers Squibb to further the understanding of how best to treat this challenging disease and help adult patients achieve their treatment goals,” he added.