Diabetes drug approved in Europe

The European Commission has approved the use of Onglyza (saxagliptin) as a combination therapy with insulin to improve glycaemic control in adults with type II diabetes.

The approval was based on a Phase IIIb study which demonstrated that Onglyza significantly reduced blood sugar levels when compared to treatment with placebo.

Howard Hutchinson, Chief Medical Officer, AstraZeneca, says the medication “helps to advance treatment of type II diabetes”.

Onglyza is indicated in adults with type II diabetes mellitus to improve glycaemic control in combination with metformin, sulphonylurea, thiazolidinedione or insulin, when each treatment alone, along with diet and exercise, has not provided adequate blood sugar level control.

It has been submitted by Bristol-Myers Squibb and AstraZeneca for regulatory review in more than 90 countries and has been approved in 68, including 30 European states.

“Since many patients with type II diabetes eventually require insulin, it is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen to reach their treatment goals,” said Brian Daniels, Senior Vice President, Global Development and Medical Affairs, Bristol-Myers Squibb.