First Biologic Therapy for Treating Allergic Asthma

A humanized monoclonal antibody is the first biologic therapy for asthma and the first treatment designed to block the IgE antibody, specifically targeting the underlying cause of allergic asthma. An advisory committee to the US Food and Drug Administration (FDA) has voted unanimously in favor of the drug being approved for treating moderate-to-severe allergic asthma in adults and adolescents. This is expected to lead to FDA approval.

In clinical trials, the injected drug, called Xolair (omalizumab), was found to reduce asthma exacerbations and enable many patients to reduce or eliminate the use of inhaled corticosteroids. The drug is administered only every two to four weeks. Xolair is being jointly developed by Novartis Pharmaceuticals AG (Basel, Switzerland), Tanox, Inc. ( Houston, TX, USA), and Genentech, Inc. (South San Francisco, CA, USA).

"We are very pleased with the positive feedback provided by the advisory committee members today,” said Cynthia Hogan, vice president, respiratory and dermatology therapeutic franchise for Novartis Pharmaceuticals Corp. "We believe that Xolair can provide benefit to an important population of allergic asthma sufferers, and we look forward to working with the FDA to make Xolair available to patients.”






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