AstraZeneca’s fixed-dose diabetes drug Xigduo approved in Europe

The European Commission has approved Anglo-Swedish drug major AstraZeneca (LSE: AZN) and soon to be ex-partner USA-based Bristol-Myers Squibb’s (NYSE: BMY) Xigduo (dapagliflozin and metformin hydrochloride) for the treatment of type 2 diabetes in the European Union.

Xigduo combines dapagliflozin (trade name Forxiga), a selective and reversible inhibitor of SGLT2 with metformin hydrochloride, two anti-hyperglycemic products with complementary mechanisms of action to improve glycemic control, in a twice daily tablet. This is the first regulatory approval for a fixed-dose combination of an SGLT2 inhibitor and metformin and follows a recent recommendation from the European Medicines Agency’s Medicinal Products for Human Use (CHMP; The Pharma Letter November 22, 2013).

Xigduo is indicated for adults aged 18 and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic 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.