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Genentech/Novartis/Tanox anti-IgE

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Two pivotal trials of anti-IgE (olizumab/rhuMAb-E25) showed a decrease in frequency of asthma exacerbations, defined as symptoms requiring a doubling of inhaled steroids or initiation of oral steroids, the firms reported. Both multicenter, randomized, double-blind studies enrolled asthma patients who were symptomatic despite inhaled corticosteroid therapy. Anti-IgE injection or placebo was administered every two to four weeks for 28 weeks. During the first 16 weeks study subjects received inhaled steroids and rescue albuterol in addition to anti-IgE or placebo. The dose of steroids was reduced during the following 12 weeks. The anti-IgE dose varied based on patient weight and serum IgE levels.
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