JanuviaTreatment for Diabetes Type 2
Merck Announces FDA Acceptance of New Drug Application for Januvia, the Company's Investigational Medicine for Type 2 Diabetes
WHITEHOUSE STATION, N.J., February 15, 2006 - Merck & Co., Inc. announced today that the New Drug Application (NDA) for Januvia (sitagliptin phosphate) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Merck expects FDA action on the NDA by mid-October. The Company also is moving forward as planned with filings in countries outside the United States.
Januvia is an investigational once-daily medicine with a novel mechanism of action for the treatment of type 2 diabetes. If approved, Januvia would potentially be the first in a new class of oral medications (DPP-4 inhibitors) that enhances the body's own ability to lower blood sugar (glucose) when it is elevated. In clinical studies, Januvia was not associated with weight gain from baseline, and the incidence of hypoglycemia (when blood sugar becomes too low) was similar to placebo. The most common side effects reported in clinical studies with Januvia were stuffy or runny nose and sore throat; headache; diarrhea; and joint pain.
"Based on our clinical studies, we believe Januvia represents a new and different approach to the treatment of type 2 diabetes," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Merck is committed to developing innovative therapies that offer advances in the treatment of serious diseases like diabetes and demonstrate clear value to patients, payors and physicians."
"The discovery and development of Januvia is a prime example of our Company's strategy to target key therapeutic areas, such as diabetes," said Dr. Peter S. Kim, president, Merck Research Laboratories. "The filing of Januvia demonstrates the ability of our research labs to efficiently develop innovative medicines, while also maintaining our strong commitment to patient safety and scientific excellence."
Januvia is Merck's investigational oral dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes.
DPP-4 inhibitors work by enhancing a natural body system that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase insulin and signal the liver to stop producing glucose. DPP-4 inhibitors enhance the body's own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.
About Type 2 Diabetes
Type 2 diabetes is a condition in which the body has elevated blood sugar or glucose. With type 2 diabetes, the body may not make enough insulin (which helps the body use glucose), the insulin that the body produces may not work as well as it should, or the body may make too much glucose. Patients with diabetes can develop heart disease, kidney disease, blindness, vascular or neurological problems that can lead to amputation and they can suffer increased mortality.
Nearly 21 million people in the United States, or seven percent of the population, have diabetes, with type 2 diabetes accounting for 90 to 95 percent of the cases. Less than 50 percent of adults with diagnosed diabetes achieve the American Diabetes Association target level of glucose control (A1C less than seven percent). It is estimated that one in three Americans born in 2000 will develop diabetes sometime during their lifetime. There are currently more than 194 million people with diabetes worldwide, and if nothing is done to slow the epidemic, the number will exceed to 333 million by 2025.
Januvia is the proposed trademark for MK-431 (sitagliptin phosphate).
Source: Merck & Co., Inc.
Posted: February 2006
- Januvia Merck & Co., Inc. - Treatment for Type 2 Diabetes - October 17, 2006