Merck Announces FDA Acceptance Of New Drug Application For JANUVIA™

JANUVIA is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. Merck & Co., Inc. announced that the New Drug Application (NDA) for JANUVIA™* (sitagliptin phosphate) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the NDA by mid-October. The Company also is moving forward as planned with filings in countries outside the United States.

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 (glucose) 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.

JANUVIA is Merck’s investigational oral dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes. DPP-4 inhibitors work by enhancing a natural body system that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase insulin and signal the liver to stop producing glucose. DPP-4 inhibitors enhance the body’s own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

Nearly 21 million people in the United States, or seven percent of the population, have diabetes, with type 2 diabetes accounting for 90 to 95 percent of the cases. Less than 50 percent of adults with diagnosed diabetes achieve the American Diabetes Association target level of glucose control (A1C less than seven percent). It is estimated that one in three Americans born in 2000 will develop diabetes sometime during their lifetime. There are currently more than 194 million people with diabetes worldwide, and if nothing is done to slow the epidemic, the number will exceed to 333 million by 2025.

*JANUVIA™ is the proposed trademark for MK-431 (sitagliptin phosphate).
Learn more about DPP-IV and GLP-1 by visiting https://www.diabetesincontrol.com/issue212/dppIV.ppt

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