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EU approval for new diabetes treatment


AstraZeneca and Bristol-Myers Squibb treatment for type 2 diabetes Xigduo has been granted Marketing Authorization by the European Commission.

Xigduo, which has the trade name Forxiga, combines dapagliflozin, a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin, states AstraZeneca.

“Metformin has long been a standard of diabetes care, and with the Xigduo approval, we now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes,” commented Elisabeth Björk, Vice President, Head of Late Phase Cardiovascular and Metabolic Development, AstraZeneca, on the announcement of the approval.

Forxiga was the first medicine in the SGLT2 class to gain regulatory approval, having received Marketing Authorisation in the EU for type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries including the United States and Australia.