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FDA Approves Merck’s Januvia

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck received approval from the FDA for Januvia for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either metformin or thiazolidinediones (TZDs), to improve blood sugar control in patients with type 2 diabetes when diet and exercise is not enough. It is the first and only DPP-4 inhibitor available in the U.S.

Januvia enhances a natural body system called the incretin system, which helps to regulate glucose by affecting the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, Januvia works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.

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