Merck diabetes drug wins federal approval
Posted 10/17/2006 9:07 AM ET
WASHINGTON (AP) - Diabetics gained a new way of controlling their blood
sugar levels Tuesday with the federal approval of a novel pill for Type 2
diabetes, which affects about 20 million Americans.
The Food and Drug Administration said it approved
Januvia, which enhances
the body's own ability to lower blood sugar levels, after clinical trials
showing the new pill works just as well as older diabetes drugs, but with
fewer side effects like weight gain. The drug is made by Merck and Co. Inc.
The new drug's cost may limit its use, however. Merck did not immediately
disclose what it would charge for Januvia, but it is expected to cost
between $3 and $6 a day. Older diabetes drugs can cost 50 cents a day.
Januvia, also known as sitagliptin phosphate, works with a one-two punch: It
increases levels of a hormone that triggers the pancreas to produce more
insulin to process blood sugar while simultaneously signaling the liver to
quit making glucose. The pill does that by blocking production of an enzyme,
called DPP-4, that normally inactivates that hormone.
Januvia is unlike any other oral drug for treating Type 2 diabetes. However,
Novartis AG hopes to win FDA approval for a similar drug later this year.
In Type 2 diabetes, patients either don't produce enough insulin or cells in
the body ignore it. Insulin is needed to process sugar. Without it, blood
sugar levels soar.
The FDA approved Januvia for use in addition to diet and exercise to improve
blood sugar levels in patients with Type 2 diabetes, alone or in combination
with other commonly prescribed drugs.
"For the millions of Americans with Type 2 diabetes, who continue to have
inadequate blood sugar control, the approval of Januvia marks an important
advance in the fight against diabetes," said Dr. Steven Galson, director of
FDA's Center for Drug Evaluation and Research. "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."
American Diabetes Association guidelines suggest diabetics cut their levels
of an averaged measure of blood sugar levels, called A1c, to less than 7%.
Many, if not most, diabetics exceed that threshold. Helping them drop below
it could reduce their risk of serious complications, like kidney failure and
amputations, the diabetes group says.
At a diabetes conference in June, Merck said Januvia lowered blood sugar
levels by 0.67% in a year-long trial, or just as much as another, older
drug,
glipizide. Roughly two-thirds of patients reached the ADA's 7% goal.
Most importantly, Merck said the Januvia patients also lost weight and
experienced fewer episodes of excessively low blood sugar than those on
glipizide, a member of the sulfonylurea class of drugs. Excess weight is a
common problem in Type 2 patients.
Analysts have predicted Januvia sales could reach $1 billion in 2009 for
Whitehouse, N.J.-based Merck.
Merck hopes to win FDA approval in late March for another pill, called
MK-0431, that combines Januvia and the diabetes drug
metformin.
"There is a huge need for additional therapeutic options in this
marketplace," said Jay Galeota, who manages Merck's global diabetes drug
business.
More than 230 million people worldwide have diabetes, up from just 30
million in 1985, according to the International Diabetes Federation.
Diabetes is expected to affect 350 million people by 2025.
Merck diabetes drug wins federal approval 
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