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Boehringer Ingelheim and Eli Lilly and Company today announced that they have received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of
Jentadueto™, which combines the DPP-4 inhibitor, linagliptin (the active ingredient in Trajenta® tablets) 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.
In clinical studies, linagliptin/metformin HCl demonstrated benefit to patients by offering another dosing option with effective glycaemic 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 glycaemic 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.
In clinical trials, statistically significant, placebo-corrected mean reductions in haemoglobin A1c (HbA1c or A1C) levels of -1.7 percent were observed in patients with inadequate glycaemic control when the maximum dose of 2.5 mg linagliptin/1,000 mg metformin HCI was administered twice daily.1 HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
In clinical studies, linagliptin/metformin HCl did not cause any significant change in body weight, and can be used alone or in combination with a sulphonylurea, a commonly prescribed medication for Type 2 Diabetes.
“The CHMP positive opinion for Jentadueto™ marks another important regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
“Across Europe many people with Type 2 Diabetes require more than one treatment to adequately manage their diabetes. As a single-tablet treatment, we believe that Jentadueto™ will help patients with Type 2 Diabetes achieve and maintain glycaemic control and improve overall wellbeing.”