Type 2 Diabetes – FDA Approves New Class Drug DDP-4 Inhibitors - Januvia

Type 2 Diabetes – FDA Approves New Class Drug DDP-4 Inhibitors - Januvia

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Today, the Food and Drug Administration (FDA) announced the approval of Januvia (sitagliptin phosphate). Januvia is a first of its kind from a new class of drugs called DDP-4 inhibitors. This new drug will help aid the body to lower elevated blood sugar levels.

FDA approved Januvia for prescription for patients with type 2 diabetes who also are following a diet and exercise program to help improve blood sugar levels. It can be used alone or in a combination with two other medication, metformin, or PPAR PPAR (peroxisome proliferator-activated receptor gamma) agonist. It can be added if the other medication along with diet and exercise do not supply enough blood sugar control.

"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."

Januvia is manufactured by Merck and Co., Inc., and will help delay the action of proteins that cause insulin to release when blood sugar rises. Januvia blocks an enzyme (dipeptidyl peptidase IV or DPP-IV) which breaks down these proteins. Preventing these proteins from being released help to control blood sugar levels.

High blood sugar levels can over time cause serious complications, which include heart disease, blindness, nerve damage, and kidney damage. When a person has type 2 diabetes their body does not make enough insulin or the person develops a resistance to insulin. Insulin is needed to make sure that the body can use sugar by transporting the energy for their body’s cells to use.

Side effects reported on the Januvia trial were upper respiratory tract infection, sore throat, and diarrhea.



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