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Merck’s Combo Diabetes Drug Accepted for Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck’s NDA for MK-0431A, an oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for review by the FDA. The company expects a decision on the NDA by the end of March 2007. The company is also filing for approval in countries outside the U.S.

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. DPP-4 inhibitors work by enhancing the body’s own ability to lower blood sugar when it’s elevated. The combination drug is designed to provide a treatment option for patients who need two or more oral agents to help control their blood sugar.

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