Merck's NDA for Januvia has been accepted for review by the FDA. Merck expects FDA action on the NDA by mid-October. The company also is moving forward with filings in countries outside the U.S.
Januvia is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. If approved, Januvia would potentially be the first in a new class of oral medications (DPP-4 inhibitors) that enhances the body's own ability to lower blood sugar when it is elevated. In clinical studies, Januvia was not associated with weight gain from baseline, and the incidence of hypoglycemia (when blood sugar becomes too low) was similar to placebo. The most common side effects were stuffy or runny nose and sore throat, headache, diarrhea, and joint pain.