Merck says FDA to review diabetes therapy NDA

By Elaine Rigoli

Tampa, Fla., July 31 - Merck & Co., Inc. said its New Drug Application 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 Food and Drug Administration.

Merck, which said it expects FDA action by the end of March 2007, is also moving forward as planned with regulatory filings in countries outside the United States.

"The majority of type 2 diabetes patients require multiple therapies to control their blood sugar. 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," president of Merck Research Laboratories Peter S. Kim said in a news release.

Merck is a global pharmaceutical company located in Whitehouse Station, N.J.

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