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FDA Approves New Treatment for Diabetes

BETHESDA, MD -- October 17, 2007 -- The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.

FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate 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 Steven Galson, MD, MPH, 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."

Type 2 diabetes is the most common form of the disease, accounting for about 90 percent to 95 percent of all diagnosed cases of diabetes (20.8 million in 2005). In type 2 diabetes, the body does not produce enough insulin or the cells ignore the insulin. Insulin is necessary to take sugar, the basic fuel for cells, from the blood into the cells. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, nerve damage, and kidney damage.

Januvia prolongs the activity of proteins that increase the release of insulin after blood sugar rises, such as after a meal. Januvia does this by blocking an enzyme (dipeptidyl peptidase IV or DPP-IV) which breaks down these proteins, leading to better blood sugar control.

Januvia was examined in a total of 2,719 patients with type 2 diabetes, in studies lasting from 12 weeks to more than a year. These studies demonstrated improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

The most common side effects in clinical studies were upper respiratory tract infection, sore throat, and diarrhea.

Januvia is manufactured by Merck and Co., Inc., Whitehouse Station, N.J.


SOURCE: U.S. Food and Drug Administration

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