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The FDA approved Xolair™, the first in a new class of asthma therapies that
are bioengineered to target IgE.
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The Food and Drug Administration approved a radically new drug, Xolair™, for patients
with serious asthma. Patients with severe allergy-related asthma may not
respond to standard therapy in the form of inhalers, antihistamines or even
steroids. Xolair, is the first in a new class of therapies that are
bioengineered to target IgE (the antibody behind allergic asthma) in the
treatment of allergic disease.
Asthma is a potentially life-threatening chronic inflammatory lung disease.
Asthma is often triggered by allergies and is characterized by airway obstruction,
wheezing and coughing.
Allergens, such as pollen and mold, and irritants, such as dust and tobacco
smoke, are among the major "triggers" for the breathing problems in asthma
patients. Allergic asthma is caused by a reaction of the body to an allergic
stimulus. The stimulus (an allergen) reacts with an antibody (IgE),
which is where Xolair works. IgE
is present in the lung attached to mast cells (the cell responsible for
the allergic reaction). As soon as the antigen (allergen) antibody reaction
takes place the mast cell dies and releases its contents. It is the chemicals
that are released by the mast cells that leads to spasm in the bronchi and
the asthmatic attack. Allergic asthma is often associated with a personal
and/or family history of allergic diseases such as rhinitis, urticaria,
and eczema, with positive wheal-and-flare skin reactions to intradermal
injection of extracts of airborne allergens, with increased levels of IgE
in the serum, and/or with a positive response to provocation tests involving
the inhalation of specific allergen.
That same reaction is behind a range of allergic ailments, from hay fever
to peanut allergy, that scientists hope Xolair one day will prove key to
treating, too.
Five Phase III clinical trials were conducted to determine the effectiveness
of Xolair in asthma (two studies) and seasonal allergic rhinitis (three
studies). In the studies, adults (ages 12-75 years) and pediatric patients
(approx. ages 6-12 years) were given either Xolair or placebo in conjunction
with other medications -- either inhaled steroids for asthma or antihistamines
for seasonal allergic rhinitis (SAR). Another study was more recently completed
in perennial allergic rhinitis (year-round allergies caused by allergens
such as dust, mold and animal dander). A BLA has been submitted for allergy-related
asthma in patients age 12 and older, also referred to as adult allergic
asthma.
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In one study, Xolair cut by one-third to one-half the number of asthma
attacks suffered by patients whose disease isn't controlled by today's standard
treatments. Many dramatically cut back or even eliminated inhaled steroids
and other asthma medications, while on Xolair.
Approximately 17 million Americans suffer from asthma, including nearly
five million children. Additionally, asthma accounts for as many as 500,000
hospitalizations each year.
Xolair will be available by prescription in late July, with a wholesale
cost of $433 per injectable vial, according to Novartis. In studies, 60
percent of patients required one vial a month and the rest two; the dose
is determined by patient size and degree of allergic reaction.
It's not clear how quickly insurance companies will cover Xolair, but
despite its high cost the drug could actually save money for many patients,
Lanier said. Add the numerous inhalers and pills that many patients require
daily, plus emergency-room and doctor visits for asthma attacks, and the
most severe patients today spend up to $25,000 a year.
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