FDA OKs New Type 2 Diabetes Drug
Drug, Called Januvia, Is 1st Approved Drug in New Class of Diabetes Drugs
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
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
By sidelining that enzyme, Januvia lets those insulin-boosting proteins last
longer, leading to better blood sugar control.
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
"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.