29 Nov2013
29 Nov2013
AstraZeneca, BMS gets positive regulatory feedback on Type 2 diabetes drug
Xigduo combines dapagliflozin, a selective and reversible inhibitor of sodium-glucose cotransporter 2 and metformin hydrochloride
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided AstraZeneca and Bristol-Myers Squibb 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 dapagliflozin and metformin as separate tablets.
