[Tn-talk] FDA OK's New Type 2 Diabetes Drug

Wed Oct 18 13:58:32 CDT 2006

For your information.
(Sorry to any who have received this from another list)
Regards,

Heather Field
FDA OKs New Type 2 Diabetes Drug

Drug, Called Januvia, Is 1st Approved Drug in New Class of Diabetes
Drugs

By Miranda Hitti
WebMD Medical News

Reviewed By Louise Chang, MD
on Tuesday, October 17, 2006

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.

SOURCES: News release, FDA. Merck: "Januvia Patient Information."
National
Institute of Diabetes and Digestive and Kidney Diseases: "National
Diabetes
Statistics." Associated Press.

Sincerely,

Christopher McMillan
Rehabilitation Engineer
http://christophermmcmillan.spaces.live.com
chrismcmillan at earthlink.net
203 404 7275 Work Number
203 286 2156 Fax Number
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