Sitagliptin, First in New Class of Diabetes Drugs, Approved

The FDA yesterday approved the type 2 diabetes treatment Januvia (sitagliptin). It's the first drug approved in a new class known as dipeptidyl peptidase 4 (DPP-4) inhibitors.

Januvia’s mechanism is glucose-dependent, according to the manufacturer, lowering the potential for hypoglycemia. It and other DPP-4 inhibitors under development work by blocking the breakdown of proteins that stimulate insulin synthesis and release when blood glucose rises. In clinical trials, use of the drug was not associated with either hypoglycemia or weight gain, and the drug lowered A1C levels by roughly 0.7%.

Januvia has been approved as a monotherapy adjunct to diet and exercise or for use in combination with metformin or thiazolidinediones. The drug will cost $4.86 per daily tablet, according to the manufacturer.

Asked to comment, Dr. Merri L. Pendergrass, director of clinical diabetes at Boston's Brigham and Women's Hospital, said "Januvia will add to the growing list of treatment options for type 2 diabetes. However, at least in the near future, the relatively high cost and lack of long-term safety data for DPP4 inhibitors will likely keep Januvia well down on the list of preferred treatments."