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FDA Approves New Asthma Drug
This year, the Food and Drug Administration approved a new drug for
the treatment of allergic asthma. Hailed as a different approach, Xolair
is a genetically engineered protein designed to target IgE antibodies
in the blood. These antibodies are chemicals in the bloodstream responsible
for starting the cascade of events leading to the inflammation and
airway constriction typical of an asthma attack. By binding to IgE
antibodies, Xolair stops the immune response to an allergen, such as
dust mites or animal dander, and prevents asthma from worsening.
This is good news for some asthma sufferers, but not all. In fact, only
a small fraction of the 17 million Americans who suffer from asthma will
benefit from the drug. Xolair is intended as a second-line therapy for
people whose asthma does not respond to inhaled steroids. Also, the drug
was approved for use only in adults and teenagers. And studies show Xolair
works only in people with moderate to severe asthma triggered by allergens.
Despite its limitations, Xolair appears to work well in its intended
audience. In clinical trials, roughly 80%-85% of patients treated with
Xolair had no asthma attacks during the six-month study period, compared
to 70%-75% of patients treated with a placebo. Patients taking Xolair
experienced side effects at a similar rate as patients who received a
placebo. The most common side effects included swelling at the injection
site (45%), viral infections (23%), and upper respiratory tract infections
(20%). Patients taking Xolair were more likely to develop or experience
a recurrence of cancer than those patients who received the placebo,
but the rates are very low (0.5% compared to 0.2%). The maker of Xolair,
Genentech, Inc., is planning long-term studies to look into the relationship
between Xolair and cancer.
Before you talk with your doctor about Xolair, keep track of your asthma
symptoms for a few weeks. This will help you and your doctor decide whether
or not your asthma is under control and at a level you are comfortable
with. You'll also need to find out if your asthma is caused by perennial
allergens - only a skin or blood test can determine this. Switching to
Xolair means frequent doctor's visits; a doctor or nurse must administer
the drug through an injection once or twice a month. If you and your doctor
decide that Xolair is right for you, be sure to also talk about how to
slowly phase out your current medication. And remember, Xolair is not designed
to halt an asthma attack once one has started.
November 2003 Update
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