FDA Approves First Biologic for Allergy-Related Asthma

FDA Approves First Biologic for Allergy-Related Asthma

The Food and Drug Administration (FDA) recently approved the first biotechnology product to treat patients with allergy-related asthma. The product, omalizumab (Xolair), is a monoclonal antibody that has been shown to be safe and effective to treat people with moderate to severe allergy-related asthma inadequately controlled with inhaled steroid treatments. Given as a subcutaneous injection, omalizumab has been shown to decrease the number of asthma exacerbations or episodes of airway narrowing that result in wheezing, breathlessness, and cough. Asthma is an airway disease affecting approximately 17 million in the US; it is estimated that a relatively small percentage of these people would be appropriate candidates for this second-line treatment, which would be recommended only after first-line treatments have failed. Omalizumab is a genetically engineered protein that blocks the immune cascade that normally occurs in response to allergens. Omalizumab is manufactured by Genentech, San Francisco, CA. Genentech will jointly market the product in conjunction with Novartis Pharmaceutical Corp., East Hanover, NJ.

Source: FDA News—June 20, 2003