XIGDUO™ (dapagliflozin and metformin hydrochloride) approved in the European Union for type 2 diabetes

AstraZeneca and Bristol-Myers Squibb today announced that Xigduo™ (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) has been granted Marketing Authorisation by the European Commission for the treatment of type 2 diabetes in the European Union (EU). Xigduo combines dapagliflozin (trade name Forxiga®), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycaemic products with complementary mechanisms of action to improve glycaemic control, in a twice daily tablet. This is the first regulatory approval for a fixed dose combination of an SGLT2 inhibitor and metformin.

Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control. It is indicated in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.

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 (available under the trade name Farxiga™) and Australia.

“Xigduo is an important addition to the range of medicines to help patients manage glycaemic control. We recognise that not all patients are alike and that different treatments are needed, supporting a more personalised approach to disease management,” said Elisabeth Björk, Vice President, Head of Late Phase Cardiovascular and Metabolic Development, 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.”

“Type 2 diabetes is a growing global concern and a range of treatments are needed in order to appropriately manage this disease,” said Fred Fiedorek, Senior Vice President, Head of Development – Cardiovascular & Metabolics, Bristol-Myers Squibb. “The approval of Xigduo offers physicians another valuable treatment choice in the management of this progressive disease.”