FDA to Review Merck Diabetes Drug Filing
Posted on: Tuesday, 1 August 2006, 21:00 CDT
Merck & Co's new drug application for MK-0431A, an investigational oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for standard review by the FDA.
MK-0431A combines the novel approach to controlling blood sugar of Merck's Januvia (sitagliptin phosphate), an investigational DPP-4 inhibitor, with metformin, a widely-prescribed medication for type 2 diabetes, in a single tablet.
"The majority of type 2 diabetes patients require multiple therapies to control their blood sugar," explained Dr Peter Kim, president of 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."
Merck expects FDA action on the new drug application by the end of March 2007. The company said that it is also moving forward as planned with regulatory filings in countries outside the US.
Source: Datamonitor
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