Drug Stops Asthma Attacks Before They Start

IgE is a key underlying cause of the symptoms of asthma that has an allergic component. The drug has been cleared by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe persistent asthma in adults and adolescents (12 years and older).

Two 52-week phase III clinical trials involved 1,071 asthma patients, who were randomized to receive subcutaneous doses of the drug or placebo every two or four weeks. Doses were determined by body weight and IgE level. Inhaled corticosteroid doses were kept stable over the initial 16 weeks of treatment and tapered during a further 12-week treatment period. When used as an add-on therapy to inhaled corticosteroids, the drug reduced mean asthma exacerbations per patient by 33-75% during the stable-steroid phase and 33-50% during the steroid-reduction phase.

Called Xolair (omalizumab), the drug is being jointly developed under an agreement among Genentech (So. San Francisco, CA, USA), Novartis (Basel, Switzerland), and Tanox (Houston, TX, USA). The drug is injected into patients once or twice a month at a yearly cost estimated at US$5,000-10,000. The developers warn that the drug should not be used for the treatment of acute bronchospasm or status asthmaticus, and that systemic corticosteriods should not be abruptly discontinued when a patient begins taking the drug.

"Xolair is a significant advance in the evolution of asthma therapy and its approval is a milestone event in bringing biologic therapies to new markets and meeting an unmet need for patients with asthma mediated by IgE,” said Arthur Levinson, Ph.D., chairman and CEO of Genentech.





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