CHMP recommends Xigduo for Type 2 Diabetes-BMS/AstraZeneca

AstraZeneca and Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has on 22 November 2013 adopted a positive opinion recommending approval of Xigduo (dapagliflozin and metformin hydrochloride) for adults aged 18 and older with Type 2 Diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their current metformin-based treatment regimen or who are currently being treated with the combination of dapgliflozin and metformin as separate tablets.Xigduo combines dapagliflozin ( Forxiga), a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride in a twice daily tablet. This is the first CHMP recommendation for a SGLT2 and metformin hydrochloride fixed dosage combination.