Merck Announces FDA Acceptance of NDA for Januvia

By October of this year, Merck & Co., Inc., expects the FDA to rule on its novel type 2 drug Januvia (sitagliptin phosphate). On February 15, 2006, the FDA accepted Merck’s New Drug Application (NDA) for Januvia for standard review.

Januvia is an investigational once-daily medicine for the treatment of type 2 diabetes. Merck says that if approved, Januvia would be the first in a new class of oral medications called DPP-4 inhibitors, which enhance the body’s own ability to lower blood glucose when it is elevated.

“Based on our clinical studies, we believe Januvia represents a new and different approach to the treatment of type 2 diabetes,” says Richard T. Clark, Merck’s chief executive officer and president. “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.”

The most common side effects of Januvia reported in clinical studies were stuffy or runny nose and sore throat, headache, diarrhea and joint pain.

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What are DPP-4 inhibitors?

DPP-4 inhibitors work by enhancing the body’s incretin system, which works to lower blood glucose. When blood glucose is elevated, incretins work in two ways to help the body regulate high blood glucose levels: They trigger the pancreas to increase insulin production, and they signal the liver to stop producing glucose. DPP-4 inhibitors enhance the body’s own ability to control blood glucose levels by increasing the active levels of incretin hormones in the body, helping to decrease blood glucose levels in patients with type 2 diabetes.

Source: Merck & Co., Inc.

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