MSD reports EU approval for Januvia

Merck, Sharp and Dohme (MSD) has announced that its diabetes treatment Januvia has been granted marketing authorisation by the European Commission.

The compound is indicated in patients with type two diabetes to improve blood sugar control in conjunction with metformin in patients for whom metformin plus diet and exercise do not provide adequate control.

It is indicated in combination with PPAR-gamma agonists in patients for whom such agonists are appropriate when diet and exercise plus the agonist, such as a thiazolidinedione, does not provide sufficient blood sugar control.

“Januvia now becomes the first and only medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DDP-4 inhibitors), which enhance the body’s own ability to lower blood sugar when it is elevated, to be adopted by the European Commission,” the company reports.

The compound operates by enhancing the body’s natural incretin system – the process by which the body lowers blood sugar by triggering the pancreatic release of insulin and reducing the liver’s production of glucose.

Last month, the US Food and Drug Authority accepted two supplemental new drug applications for an expansion of the labelling of Januvia in the US to include a combination with metformin and as an adjunctive therapy with sulfonylurea.