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Senior Citizen Health & Medicine
FDA Anoints Januvia as New Super Star in Fighting
Type 2 Diabetes
Merck drug is first
approved in a new class called DPP-4 inhibitors
October 18, 2006 – The world probably looks much
different this morning to millions of senior citizens battling type 2
diabetes. A whole new way of fighting the debilitating disease was
introduced yesterday with the Food and Drug Administration's approval of
Januvia (sitagliptin phosphate). It is the first approved of a new class
of drugs known as DPP-4 inhibitors that enhances the body's ability to
lower elevated blood sugar. Not far behind in the approval process is a
similar drug named Galvus. Experts say the commercial potential is
"gigantic."
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Januvia may have a profound impact on medical
practice for type 2 diabetes by delaying the progression of the disease,
according to Donny Wong, Ph.D., analyst at publihser Decision Resources.
Wong, author of Emerging Therapies in Type 2
Diabetes, says Januvia is the first oral drug targeting the incretin
pathway. He says it will capitalize on the success of the very first
drug targeting this pathway, Amylin/Eli Lilly's Byetta. Byetta has had
tremendous success in the market despite its twice-daily injectable
formulation.
His book reports on Januvia, as well as Novartis's
Galvus, which is in the same class, has nearly an identical clinical
profile to Januvia, and will likely be approved by November 30, 2006.
"We believe this is a huge and growing market given
the number of patients who do not reach goal, or harbor concerns about
weight gain and hypoglycemia," Jami Rubin of Morgan Stanley noted. "We
are increasingly of the view that our $1.2 billion forecast by 2010 is
too conservative."
The FDA says it 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 two other commonly
prescribed oral diabetes medications, metformin or a PPAR (peroxisome
proliferator-activated receptor gamma) agonist, when either of these
drugs alone, along with diet and exercise, don't provide adequate blood
sugar control.
"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."
Type 2 diabetes is the most common form of the
disease, accounting for about 90 percent to 95 percent of all diagnosed
cases of diabetes (20.8 million in 2005).
A study last May found that 22 percent of senior citizens age 65 and
older have diabetes and nearly 40 percent suffer with a form of
pre-diabetes called impaired fasting glucose.
In type 2 diabetes, the body
does not produce enough insulin or the cells ignore the insulin. Insulin
is necessary to take sugar, the basic fuel for cells, from the blood
into the cells. Over time, high blood sugar levels can increase the risk
for serious complications, including heart disease, blindness, nerve
damage, and kidney damage.
Januvia prolongs the activity of proteins that
increase the release of insulin after blood sugar rises, such as after a
meal. Januvia does this by blocking an enzyme (dipeptidyl peptidase IV
or DPP-IV) which breaks down these proteins, leading to better blood
sugar control.
Januvia was examined in a total of 2,719 patients
with type 2 diabetes, in studies lasting from 12 weeks to more than a
year. These studies demonstrated improved blood sugar control when
Januvia was used alone or in patients not satisfactorily managed with
metformin or a PPAR agonist.
The most common side effects in clinical studies
were upper respiratory tract infection, sore throat, and diarrhea.
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