AstraZeneca and Bristol-Myers Squibb receive EU Xigduo approval

AstraZeneca and Bristol-Myers Squibb have been granted European Commission approval for their new type 2 diabetes therapy Xigduo.

Consisting of dapagliflozin plus metformin hydrochloride, the new product combines two anti-hyperglycaemic agents with complementary mechanisms of action into a single twice-daily tablet.

The marketing authorisation covers the use of Xigduo to improve glycaemic control among adult diabetes patients as an adjunct to diet and exercise. It is indicated for patients inadequately controlled on metformin-based treatment regimens, or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.

Clinical studies have confirmed the positive safety and efficacy performance of the new combination therapy, making it a potentially valuable new option for the treatment of type 2 diabetes.

Elisabeth Bjork, vice-president and head of late-phase cardiovascular and metabolic development at AstraZeneca, said: "We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management."

This comes after it was announced last month that AstraZeneca is to purchase the global diabetes business of Bristol-Myers Squibb, acquiring full rights to all assets pertaining to the research alliance between the two companies.