- The European Medicine Agency's advisory group CHMP has adopted a positive opinion recommending approval of AstraZeneca's (NYSE:AZN) Qtrilmet (850 mg metformin hydrochloride, 2.5 mg saxagliptin and 5 mg dapagliflozin or 1000 mg metformin hydrochloride, 2.5 mg saxagliptin and 5 mg dapagliflozin) to improve glycaemic control in adults with type 2 diabetes (T2D) when metformin with or without sulphonylurea and either saxagliptin or dapagliflozin does not provide adequate glycaemic control and who are already receiving metformin and saxagliptin and dapagliflozin.
- A final decision from the European Commission usually takes ~60 days.