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 Tuesday, 1st July 2003


The FDA approved Xolair?, the first in a new class of asthma therapies that are bioengineered to target IgE.


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Bronchodilator drug info


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.

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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