DEERFIELD, Ill., Nov. 16 /PRNewswire/ -- Fujisawa Healthcare announced
today that the U.S. Food and Drug Administration (FDA) Dermatologic and
Ophthalmic Advisory Committee found PROTOPIC (tacrolimus) ointment to be safe
and effective for the treatment of moderate to severe atopic dermatitis, more
commonly known as eczema. The 0.1% concentration of tacrolimus ointment was
recommended for the treatment of adults and the lower 0.03% concentration for
treatment in both children and adults for long-term intermittent therapy in
patients not adequately responsive to, or intolerant of, conventional therapy.
PROTOPIC, the first in a new class of drugs to treat eczema in more than 40
years is a steroid-free option supported by positive clinical trial results.
"The medical community is constantly looking for new therapeutic options
for the treatment of eczema," says Dr. Amy Paller, pediatric dermatologist at
Children's Memorial Hospital, Chicago, Ill. "Today's recommendations
regarding the use of Protopic in the 0.1% concentration for adults and the
0.03% concentration in children and adults, takes prescribing physicians one
step closer to a steroid-free alternative to help treat all age groups
suffering from eczema."
PROTOPIC's safety and effectiveness was based on 28 worldwide clinical
studies of more than 4,000 adults and children (as young as 24 months of age)
conducted in the United States, Europe and Japan. U.S. clinical trials
included randomized, double-blind, placebo-controlled, 12-week studies with
patients suffering from moderate to severe eczema. Patients in the study were
randomized to apply either 0.03% or 0.1% tacrolimus ointment or placebo as a
thin layer twice daily to the skin. Patients were evaluated at the beginning
of the study and at weeks one, three, six, nine, 12 and at two weeks post-
treatment. Over one-third of patients were children. The study data reported
that both concentrations of PROTOPIC significantly improved or completely
cleared the signs and symptoms of the disease in more than 2/3 of the
patients. In fact, many patients showed marked improvement in just one week
of treatment.
Overall, there was a statistically significant greater efficacy of the
0.1% concentration compared to 0.03% in adults. Furthermore, certain adult
subsets achieved an even greater benefit with use of the higher 0.1%
concentration.
There was general agreement among the committee members that, because the
effect of ultraviolet light on skin treated with tacrolimus ointment is
unknown, patients should use safe sun practices to avoid exposure to natural
or artificial sunlight. Some patients reported skin burning and itching
associated with the application of PROTOPIC, however the incidences of these
events decreased as the disease improved.
PROTOPIC is the first in a new class of drugs called topical
immunomodulators, or TIMs, in more than 40 years for the treatment of eczema.
PROTOPIC works on the skin at the site of the immune imbalance to help stop
the redness and itching of the eczema inflammation.
Eczema is a chronic, life-altering disease affecting 15 million children
and adults nationwide and is characterized by painfully red, swollen, itchy,
flaky skin. In some cases the itching and redness is so vast and intense that
sufferers can scratch themselves until they bleed, increasing the risk of
secondary infection. The majority of eczema cases are diagnosed early in
childhood. While 40 percent of children suffering from eczema outgrow the
disease, others live with it throughout their entire lives.
Since 1970 the prevalence of atopic dermatitis has nearly tripled.
Studies show that the steady increase of this chronic condition is generally
attributed to irritants and allergens that trigger the immune system.
Emotional factors such as stress can also influence and worsen the condition.
For sufferers, especially children and teenagers, the visibility of eczema
flares can lead to a low self-esteem and often the inability to interact with
others.
"This is an important day for Fujisawa and its mission to help the
millions of eczema sufferers," said Ira D. Lawrence, M.D., senior vice
president research and development, Fujisawa Healthcare. "Our goal is to fill
an unmet medical need by bringing a new treatment to patients and provide hope
to those suffering from this debilitating condition."
PROTOPIC is Fujisawa's first major entry into the dermatological market --
a specialty with a clear unmet medical need and a significantly large
dissatisfied patient base. Marketing approval was obtained in Japan for
tacrolimus ointment in June 1999.
Fujisawa Healthcare, Inc. headquartered in Deerfield, Ill., develops,
manufactures and markets proprietary pharmaceutical products in the United
States and abroad. Fujisawa Healthcare, Inc., is a subsidiary of Fujisawa
Pharmaceutical Co., Ltd., based in Osaka, Japan.
Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a leading
pharmaceutical manufacturer and is actively developing its international
operations in North America, Europe and Asia. Additional information on
Fujisawa Healthcare, Inc., and its products can be found on the Company's Web
site at http://www.fujisawa.com .
SOURCE Fujisawa Healthcare, Inc.
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Related links:
http://www.fujisawa.com
CONTACT:
Maribeth Landwehr of Fujisawa Healthcare,
847-317-8988, or Meg Gorham of Leo Burnett PR, 312-220-4700, for
Fujisawa Healthcare
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