Novartis/Genentech/Tanox Xolair
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Two monkey fatalities in a study of rhuMAb-E-26, a second-generation version of Xolair, resulted in termination of clinicial trials of the asthma and allergy treatment. Thrombocytopenia observed in nonclinical toxicology studies of Xolair also led to the trials' termination. One trial on partial hold will continue but will not enroll new patients. A BLA for the monoclonal antibody was submitted Jun