| " The U.S. Food and Drug Administration's
(FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted unanimously
May 15 that the anti-IgE drug omalizumab for injection (trade name
Xolair) be approved for the treatment of moderate-to-severe allergic
asthma in adults and adolescents.
" Anti-IgE is one of the major breakthroughs in allergy treatment
over the past 30 years. It's different from other treatments because
it actually stops the allergic reaction before it begins by blocking
the IgE antibody, an underlying cause of allergic asthma. It is
administered by injection every two to four weeks.
" The May 15 unanimous vote signaled the FDA PADAC committee's
agreement that the benefits of the treatment outweigh any potential
risks. Initial FDA briefing reports issued in advance of the May
15 meeting addressed potential risks, including a possible link
between anti-IgE and increased incidence of cancer among study participants.
Clinical investigators and an independent panel of oncologists who
reviewed the study data found no statistically significant link
between the treatment and risk of cancer. The clinical data did,
however, show strong evidence of effectiveness.
" Other therapies treat the symptoms or they modify the immune
system's reaction to specific allergens. For example, allergy shots
are prescribed after tests that determine whether you're allergic
to cats, or ragweed or other allergens. Over time, the shots decrease
your body's hypersensitivity and reactions to those allergens. Antihistamines
work by blocking the effects of histamines so that allergic symptoms
are not triggered in response to contact with allergens.
" Although research continues on anti-IgE for allergic rhinitis
and peanut allergy, for now the treatment is approved only for patients
age 12 and older with moderate-to-severe allergic asthma. These
are patients who will finally get some relief after failing with
other treatments, and will find that anti-IgE greatly reduces their
reliance on other medications.
" 50 million people have asthma or allergies and many of them
either don't have their condition under control or they need to
take medications all day long. Allergic asthma is asthma that's
triggered by an allergic reaction to something - animal dander,
ragweed, grass, dust mites. About 17 million people have asthma;
about half of all adult cases are allergic asthma and about 80 percent
of pediatric cases are allergic asthma.
" For people who will not be candidates for anti-IgE treatment,
many of them could be doing more to control their asthma. Despite
advances in asthma prevention, diagnosis and treatment, asthma is
still one of the most common chronic diseases, causing 5,000 deaths
each year.
" Peak allergy season is approaching and allergies and asthma
will keep many people home from work and school. Many asthma sufferers
who don't have their disease under control, including many with
mild to moderate asthma, will unnecessarily end up in a hospital
or emergency room.
" The American College of Allergy, Asthma and Immunology (ACAAI)
has created guidelines to help asthma patients determine if they
are getting the most effective care. The asthma treatment guidelines,
available in the news section of the College's Web site, www.acaai.org,
provide five asthma management components that patients should expect
their physician to provide.
" Additional information about specific costs and coverage
by insurance providers is expected from the pharmaceutical manufacturers
(Genentech, Novartis and Tanox, Inc.) once anti-IgE receives final
FDA approval for allergic asthma, which is anticipated in June.
The drug will be administered under specialist care, and although
it is expected to be expensive at the outset, allergists are hopeful
that insurance providers will assist patients by covering some of
that cost.
" Additional information on anti-IgE clinical study results
are available in a February 2002 review article by ACAAI president,
William E. Berger M.D., M.B.A, published in Annals of Allergy, Asthma,
& Immunology, Volume 88, p. 152. The article, titled "Monoclonal
anti-IgE antibody: a novel therapy for allergic airways disease,"
is available to ACAAI members online at www.acaai.org.
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