EMA unit backs approval of Jentadueto; Agency updates on Pradaxa

Independent German drug major Boehringer Ingelheim and US partner  Eli Lilly (NYSE: LLY)  have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending approval of their diabetes drug Jentadueto, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta) and metformin in a single tablet.

If approved by the European Commission, linagliptin/metformin hydrochloride (HCl) will provide a new, single-tablet treatment option, taken twice-daily, for adults with type 2 diabetes who need to improve control of their blood glucose. 1 In clinical studies, linagliptin/metformin HCl demonstrated benefit to patients by offering another dosing option with effective glycemic control and a favourable side effect profile.

The CHMP has recommended the approval of linagliptin/metformin hydrochloride (HCl) for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin.