Merck announces FDA accepts application for diabetes drug Januvia

By Elaine Rigoli

Tampa, Fla., Feb. 15 - Merck & Co., Inc. announced Wednesday that its New Drug Application for Januvia, an investigational once-daily drug for type-2 diabetics, has been accepted for standard review by the Food and Drug Administration.

If approved, Januvia would potentially be the first in a new class of oral medications (DPP-4 inhibitors) that enhances the body's ability to lower elevated blood sugar (glucose), according to a company release.

In clinical studies, Januvia was not associated with weight gain from a baseline, and the incidence of hypoglycemia (when blood sugar becomes too low) was similar to a placebo. The most common side effects reported in clinical studies were stuffy or runny nose, sore throat, headache, diarrhea and joint pain.

Nearly 21 million people in the United States, or 7% of the population, have diabetes, with type-2 diabetes accounting for 90% to 95% of the cases. There are currently more than 194 million people with diabetes worldwide, and if nothing is done to slow the epidemic, the number will exceed 333 million by 2025, according to a company release.

Merck is a research-driven pharmaceutical company headquartered in Whitehouse Station, N.J.

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