Janumet
sitagliptin and metformin
Treatment for Diabetes Mellitus Type IIMerck Announces FDA Acceptance of NDA for MK-0431A
WHITEHOUSE STATION, N.J., July 31, 2006 - Merck & Co., Inc. today announced that the New Drug Application (NDA) for MK-0431A, the Company's investigational oral medicine combining Januvia (sitagliptin phosphate) with metformin for type 2 diabetes, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the NDA by the end of March 2007. The Company is also moving forward as planned with regulatory filings in countries outside the United States.
MK-0431A is an investigational treatment for type 2 diabetes that combines the novel approach to controlling blood sugar of Januvia, an investigational DPP-4 inhibitor, with metformin, a widely-prescribed medication for type 2 diabetes, into a single tablet. MK-0431A is designed to provide an important treatment option for patients who need two or more oral agents to help control their blood sugar.
The mechanism of action of DPP-4 inhibitors is distinct from that of metformin and all other drugs in the currently available classes of glucose-lowering agents. DPP-4 inhibitors work by enhancing the body's own ability to lower blood sugar (glucose) when it is elevated.
"The filing of MK-0431A demonstrates Merck's commitment to the treatment of serious diseases like type 2 diabetes," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "The development programs for Januvia and MK-0431A are strong examples of Merck's strategy to develop innovative products."
"The majority of type 2 diabetes patients require multiple therapies to control their blood sugar," said Dr. Peter S. Kim, president, Merck Research Laboratories. "MK-0431A could potentially be the first fixed-dose tablet of a DPP-4 inhibitor combined with a widely used and long-standing mainstay of type 2 diabetes treatment, metformin."
Source: Merck & Co., Inc.
Related Articles:
FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet - April 2, 2007
Merck Announces Janumet, the Trademark for its Investigational Combination Therapy of Sitagliptin Phosphate and Metformin for Type 2 Diabetes - December 1, 2006
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