FDA Approves Xolair for Allergy-Related Asthma


June 20, 2003 -- The Food and Drug Administration (FDA) today approved the first biotechnology product to treat patients with a type of asthma that is related to allergies.

The product, omalizumab, is a monoclonal antibody. It has been shown to be safe and effective to treat people 12 years of age and older with moderate to severe allergy-related asthma inadequately controlled with inhaled steroid treatments. In these patients, omalizumab, marketed as Xolair, has been shown to decrease the number of asthma exacerbations or episodes of airway narrowing that result in wheezing, breathlessness, and cough. The product is given as an injection under the skin. Asthma is an airway disease affecting approximately 17 million Americans. It is estimated that a relatively small percentage of these people would be appropriate candidates for this new drug. It is a second-line treatment, recommended only after first-line treatments have failed. However,it is not approved for children under the age of 12. Moreover, it is known to work and is approved only for patients with moderate to severe, allergy-related asthma.

While the cause for most forms of asthma is unclear, asthma caused by allergies is better understood. It results from the immune system's over-reaction to inhaled allergens such as dust mites or animal dander. The body forms antibodies in response to the allergen. Then, this immune system reaction prompts inflammation causing airway narrowing and other symptoms. Xolair is a genetically engineered protein that blocks this immune response.

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