Merck expects FDA action on the NDA by mid-October, and is moving forward as planned with filings in countries outside the US.
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 reported in clinical studies with Januvia were stuffy or runny nose and sore throat; headache; diarrhea; and joint pain.
“Based on our clinical studies, we believe Januvia represents a new and different approach to the treatment of type 2 diabetes,” said Richard Clark, CEO and president, Merck & Co. “Merck is committed to developing innovative therapies that offer advances in the treatment of serious diseases like diabetes and demonstrate clear value to patients, payors and physicians.”