Xolair Advisory Committee Review Expected By Mid-2001, Tanox Says
Executive Summary
Tanox is expecting an FDA advisory committee review for the Novartis/Genentech asthma treatment Xolair (omalizumab) during the first half of 2001.
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Novartis/Genentech Xolair
Clinical trials of the allergy and asthma treatment omalizumab are placed on hold after two monkey fatalities in a study of rhuMAb-E-26, a second-generation version of Xolair. The termination was also attributed to thrombocytopenia observed in nonclinical toxicology Xolair studies. One Xolair trial on partial hold will continue but will not enroll new patients. A BLA for Xolair has been pending at FDA since late August