Jentadueto Receives European Commission Marketing Authorisation
European regulators have given approval to Boehringer Ingelheim and Eli Lilly’s diabetes combo drug, Jentadueto.
The pharmaceutical organisations announced earlier today that they received marketing authorisation from the European Commission (EC) for Jentadueto, which combines metformin with the dipeptidyl peptidase (DPP)-IV inhibitor Trajenta (linagliptin) in a single pill.
The approval was expected after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended the combination at the end of May.
The drug has been approved for use in conjunction with 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, metformin and a sulphonylurea, or those currently being treated with the combination of linagliptin and metformin. It may also be used with a sulphonylurea.
In a 24-week, randomised, double-blind, placebo controlled study assessing 791 patients with type 2 diabetes and inadequate glycaemic control with diet and exercise, 2.5 mg linagliptin/1,000 mg metformin HCl twice daily confirmed the following:
- statistically significant, placebo-corrected mean HbA1c reductions of -1.7 percent
- statistically significant reductions in fasting plasma glucose (FPG) of -60 mg/dL. FPG is used to determine glucose levels in a fasting state (usually upon waking in the morning)
Professor Klaus Dugi, head of medicine at Boehringer, commented that “many patients need more than one treatment to adequately manage their diabetes” and Jentadueto “offers a simplified, single tablet dosing option, to improve glycaemic control and with a favourable side effect profile.” The drug combination was approved in the US at the end of January this year.
Linagliptin (5 mg, once-daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the US, and Trazenta in Japan, alongside additional markets.
Jentadueto and Trajenta are the main drugs in the worldwide diabetes alliance established by Boehringer and Eli Lilly in January 2011. The agreement also includes the German company’s empagliflozin, a sodium-dependent glucose co-transporter-2 (SGLT-2) inhibitor and two of the US major’s basal insulin analogue candidates.