Merck's Januvia Wins Approval in Europe

Merck announced today that the European Commission has approved its once-a-day oral treatment for Type 2 diabetes, Januvia. The drug is the first in the new class known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) to be approved in the European Union (EU).

Januvia (sitagliptin phosphate) is indicated for improving glycemic control, in combination with metformin, when diet and exercise do not provide adequate control. For patients with Type 2 diabetes in whom use of a PPAR-gamma agonist — a thiazolidinedione — is appropriate, Januvia is indicated in combination with the PPAR-gamma agonist when diet and exercise plus the thiazolidinedione alone do not provide adequate control.

The approval applies to all 27 EU member countries, as well as Norway and Iceland, Merck said. The company said it will launch the drug shortly. Januvia has now been approved in 42 countries, including the U.S.

DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins trigger the pancreas to increase the release of insulin and signal the liver to reduce its production of glucose.