FDA APPROVES FIRST DRUG IN A NEW CLASS OF DIABETES TREATMENTS

The FDA announced today it has approved Merck's Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.

FDA approved the drug for use in concert with 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 peroxisome proliferator-activated receptor (PPAR) gamma agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.

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) that breaks down these proteins, leading to better blood sugar control. The drug was studied in a total of 2,719 patients with Type 2 diabetes, in trials 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.