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Xolair Pediatric Indication Is Too Broad, Clinical Effect Too Small For FDA Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

Seven-seven split on first key vote on "clinically meaningful beneficial effect" of omalizumab in children above age six sends decision on BLA back to FDA - not a friendly venue for sponsors Genentech and Novartis. The three FDA staffs involved in the BLA review (pediatric, pulmonary and drug safety) are united in opposition to current application.
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