First in New Class of Diabetes Drugs Cleared
Merck & Co. has received approval of its New Drug Application (See FDA News, April 2006) for Januvia (sitagliptin phosphate) tablets, the first in a new class of drugs known as DPP-4 inhibitors.
These agents enhance the body's ability to lower elevated blood glucose in patients with type 2 diabetes. The indication is for use in conjunction with diet and exercise to improve blood glucose levels alone or in combination with two other oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when further blood-sugar control is needed.
The drug prolongs the activity of proteins that heighten the release of insulin after glucose level rises, such as after a meal.