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Article: FDA Advisory Committee Unanimously Recommends Approval of Xolair; Potential First Biologic Treatment for Allergic Asthma Targets Underlying Cause of Disease.
- Article from:
- Business Wire
- Article date:
- May 15, 2003
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Business Editors/Health/Medical Writers
BIOWIRE2K
GAITHERSBURG, Md.--(BUSINESS WIRE)--May 15, 2003
Genentech, Inc. (NYSE: DNA), Novartis Pharmaceuticals Corporation, an affiliate of Novartis AG (NYSE: NVS) and Tanox, Inc. (Nasdaq: TNOX) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted unanimously that Xolair(TM) (omalizumab) for Injection be approved based on a favorable risk-benefit profile for the treatment of moderate-to-severe allergic asthma in adults and adolescents. Xolair represents a novel treatment approach as the first humanized monoclonal antibody developed ...