Regulators in Europe have given the green light to Boehringer Ingelheim and Eli Lilly's diabetes combination treatment Jentadueto.
The companies have received marketing authorisation from the European Commission for Jentadueto, which combines metformin with the dipeptidyl peptidase (DPP)-IV inhibitor Trajenta (linagliptin) in a single tablet. The thumbs-up was expected after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the combo at the end of May.
Specifically, the EC has approved Jentadueto 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, metformin and a sulphonylurea, or those already being treated with the combination of linagliptin and metformin. It may also be used with a sulphonylurea.
Klaus Dugi, head of medicine at Boehringer, noted 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 combo was approved in the USA at the end of January.
Jentadueto and Trajenta are the lead drugs in the worldwide diabetes alliance set up by Boehringer and Lilly in January 2011. The pact 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.