Pharmaceutical Business review

Merck diabetes drug gets EC license

Januvia is now the first 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 glycemic control in combination with metformin when diet and exercise plus metformin do not provide adequate glycemic 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 glycemic control.

Januvia is now approved for use in 42 countries around the world including Mexico, the US, and the Philippines.

In October 2006, the 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 control in patients with type 2 diabetes when diet and exercise are not enough.