FDA OKs New Type 2 Diabetes Drug

Oct. 17, 2006 -- People with type 2 diabetes have a new treatment option: a drug called Januvia.

Januvia is the first in a new class of drugs called DPP-4 inhibitors that help the body control high blood sugar.

Januvia comes in tablets; patients take the medication once per day.

The drug may be used with diet and exercise to improve blood sugar levels in patients with type 2 diabetes.

Januvia may also be taken with the oral diabetes drugs metformin, Avandia, or Actos when any of those drugs, along with diet and exercise, don't adequately control blood sugar.

Metformin is sold as Glucophage and as generic metformin.

Treating Type 2 Diabetes

Nearly 21 million people in the U.S. have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases.

That figure includes more than 14 million people diagnosed with diabetes and about 6 million with undiagnosed diabetes.

Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes, according to the FDA.

Type 2 diabetes is "very, very common," the FDA's Robert Meyer, MD, told reporters in a news conference.

"There are a number of other oral medications available," notes Meyer. He directs the FDA's Office of Drug Evaluation ll.

"Not everybody optimally responds to each medication and not everybody can tolerate each medication," Meyer says. "So having a new drug in a new class for such a widely prevalent disease is important in and of its own right."

How Januvia Works

In type 2 diabetes, the body doesn't produce enough insulin -- a hormone that controls blood sugar -- or doesn't respond properly to insulin.

Over time, uncontrolled high blood sugar can make serious problems -- including heart disease, blindness, nerve damage, and kidney damage -- more likely.

Januvia prolongs the activity of proteins that boost the release of insulin after blood sugar rises, such as after a meal.

Januvia does this by blocking an enzyme called DPP-IV, which breaks down these proteins.

By sidelining that enzyme, Januvia lets those insulin-boosting proteins last longer, leading to better blood sugar control.

Drug's Studies

Januvia's studies lasted from 12 weeks to more than a year and included more than 2,700 people with type 2 diabetes.

The studies showed improved blood sugar control when Januvia was used alone or with metformin, Actos, or Avandia.

The most common side effects seen in Januvia's clinical studies were upper respiratory tract infection, sore throat, and diarrhea.

Januvia hasn't been studied in children less than 18 years old, according to the drug's patient information.

Januvia's maker, the drug company Merck, will do further studies on people taking Januvia with insulin and other diabetic medications, the FDA notes.

However, Meyer says the FDA feels "comfortable enough" with Januvia's study data not to require any special studies on the drug's safety.

"Obviously, all drugs approved by the FDA are closely followed for post-approval safety experience," Meyer says. "But we felt after a review of a rather robust safety program that the data were sufficiently reassuring that we didn't think there was any special program needed to look at the safety postapproval."

Other Drugs in the Works

The Associated Press reports that Merck is expected to charge $4.86 per pill for the once-daily Januvia. Older diabetes drugs can cost 50 cents per day.

Other DPP-4 inhibitors are also in the works. The drug company Novartis -- also a WebMD sponsor -- has submitted one such drug, tentatively called Galvus, which is under FDA review.