Bristol-Myers Squibb (BMS) and AstraZeneca's type 2 diabetes therapy Onglyza (saxagliptin) has extended its licence in Europe.
The drug can now be used, with or without metformin, as a combination therapy with insulin to improve blood sugar control in adult patients with type 2 diabetes.
Dr Howard Hutchinson, chief medical officer, AstraZeneca, said: “The European approval of Onglyza as combination therapy with insulin helps to advance treatment of type 2 diabetes, by offering physicians another option to help patients manage this chronic and progressive disease.”
The approval was based on phase III trial data showing Onglyza significantly reduced blood sugar levels in adult patients with type 2 diabetes compared to treatment with placebo added to insulin.
It means that in Europe Onglyza is now indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, sulphonylurea, thiazolidinedione or insulin, when each treatment alone, with diet and exercise, does not provide adequate glycaemic control.
The news comes the week after rival DPP-4 inhibitor, Takeda's combination therapy of alogliptin and metformin, was filed for approval in the US.
The DPP-4 inhibitor field of oral hypoglycaemics treatments is currently dominated by Merck & Co's Januvia (sitagliptin) with sales of nearly $850m in the third quarter.
Onglyza, which is currently approved in 68 countries, including the US, Canada, Mexico, India, Brazil and China, was developed as part of a collaboration between BMS and AstraZeneca.
Established in January 2007, this focuses on the research, development and commercialisation of select investigational drugs for type 2 diabetes.
The European Commission has also granted approval to AstraZeneca and BMS' fixed dosed combination of and metformin HCl immediate-release, called Komboglyze.
The indication is for use as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with type 2 diabetes mellitus inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of saxagliptin and metformin as separate tablets.