FDA advisory committee unanimously recommends approval of Xolair(TM)
Potential first biologic treatment for allergic asthma targets underlying cause of disease
Basel, 16 May 2003 - Novartis announced today that the US Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted unanimously that Xolairä (omalizumab) for injection be approved based on a favourable risk benefit profile for the treatment of moderate-to-severe allergic asthma in adults and adolescents. Xolair represents a novel treatment approach and is the first humanized monoclonal antibody developed for the treatment of allergic asthma; it is the only allergic asthma treatment designed to block the IgE antibody, specifically targeting an underlying cause of allergic asthma. Based on the outcome of the Advisory Committee meeting, the sponsors will conduct further discussions with the FDA regarding product labeling and post-marketing commitments.
