Wednesday, October 18, 2006

NEWS - FDA Approves JANUVIA for Type 2 Diabetes

FDA Approves Once-Daily JANUVIA(TM), the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes

Oct 17, 2006 11:01:00 AM

WHITEHOUSE STATION, N.J., October 17 /CNW/ - Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates as Merck, Sharp & Dohme (MSD) in countries outside the U.S., announced today that the U.S. Food and Drug Administration (FDA) approved JANUVIA(TM) (sitagliptin phosphate), the first and only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. JANUVIA has been approved as monotherapy and as add-on therapy to either of two other types of oral diabetes medications, metformin or thiazolidinediones (TZDs), to improve blood sugar (glucose) control in patients with type 2 diabetes when diet and exercise is not enough. The recommended dose of JANUVIA is 100 mg once daily. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Redwood Consultants, LLC

JANUVIA enhances a natural body system to significantly lower elevated blood sugar
JANUVIA belongs to a new breakthrough class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors that improves blood sugar control in patients with type 2 diabetes. 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.

"Those patients who are unable to adequately manage their type 2 diabetes with lifestyle changes, like healthy eating and increased physical exercise, and who require medications now have a new product to help regulate their blood sugar levels," said Edward S. Horton, M.D., director of clinical research, Joslin Diabetes Center and professor of medicine, Harvard Medical School, Boston.

"JANUVIA underscores MSD's commitment to the field of diabetes, and the benefits we strive to bring to patients and physicians who struggle in the treatment of type 2 diabetes," said Richard T. Clark, president and chief executive officer, Merck & Co., Inc. "The approval of JANUVIA is a clear example of MSD's focus on developing innovative therapies to improve human health around the world."

JANUVIA had an overall incidence of side effects comparable to placebo
In clinical trials, JANUVIA demonstrated an overall incidence of side effects comparable to placebo. The most common side effects reported with JANUVIA (greater than or equal to 5 percent and higher than placebo) were stuffy or runny nose and sore throat, upper respiratory infection, and headache.

Read more on the JANUVIA announcement here


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