FDA APPROVES FIRST TREATMENT IN NEW CLASS OF DIABETES DRUGS
The FDA has approved the first treatment in a class of new diabetes drugs that improve the body's ability to decrease high blood-sugar levels, giving drug manufacturer Merck another potential blockbuster to add to its portfolio.
Januvia is the first DPP-4 inhibitor available in the U.S. Along with diet and exercise, the drug can improve blood-sugar levels in patients with Type II diabetes, the most common form of the disease. Ninety to 95 percent of all diagnosed diabetes cases are Type II, according to the FDA.
In clinical studies, approximately twice as many patients reached their goal blood-glucose levels with Januvia compared with those taking a placebo, Merck said.
But while Merck may have the only DPP-4 inhibitor on the market, it probably won't for very long. Novartis also has a DDP-4 drug, Galvus, which is awaiting FDA approval. Representatives from the FDA declined to comment on Galvus' status in a press conference the agency held Oct. 17, but the company says it expects the agency to act on the application by the end of this year.
Januvia tablets can be used alone or with two other treatments, metformin or PPAR (peroxisome proliferator-activated receptor) gamma agonists such as Actos or Avandia. When used with the other treatments, Januvia deals with all three main defects that cause poor glucose control, Merck said.
The FDA hailed the product as a breakthrough diabetes treatment. "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," said Steven Galson, CDER director.
DDP-4 inhibitors have been approved for use in other countries, but Januvia is the first to be approved in the U.S. DDP-4 inhibitors work by blocking the enzyme dipeptidyl peptidase IV, which breaks down proteins that increase the release of insulin when blood sugar rises. By stopping this enzyme, DDP-4 inhibitors allow the body to better regulate its blood sugar.