Januvia (sitagliptin), Merck & Co., Inc.'s once-a-day oral treatment for patients with type 2 diabetes, has been granted a licence from the European Commission.
Januvia now becomes the first and only medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body's own ability to lower blood sugar when it is elevated, to be adopted by the European Commission.
Januvia is indicated in patients with type 2 diabetes to improve glycaemia control in combination with metformin when diet and exercise plus metformin do not provide adequate glycaemia control. For patients with type 2 diabetes in whom use of a PPAR-gamma agonist is appropriate, Januvia is indicated in combination with the PPAR-gamma agonist when diet and exercise plus the PPAR-gamma agonist alone do not provide adequate glycaemia control.
The adoption applies to all of the 27 countries that are members of the European Union (EU), including the United Kingdom, Germany, France, Italy and Spain, as well as Norway and Iceland (who follow European Medicines Evaluation Agency (EMEA) decisions). Januvia will be launched shortly in the EU countries. Januvia is now approved for use in 42 countries around the world including Mexico, the United States, and the Philippines.
In October 2006, the US Food and Drug Administration (FDA) approved Januvia as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise are not enough.
The recommended dose of Januvia is 100 mg once daily. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
In clinical trials, Januvia demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with Januvia were stuffy or runny nose and sore throat, upper respiratory infection, and headache.
Januvia is an oral, once-daily, selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels, they trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose.