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BioPharmaceutical

Zavesca User Fee Goal In August; EU Review Raises Neurotoxicity Concerns

This article was originally published in Pharmaceutical Approvals Monthly

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  • Pharmaceutical Approvals Monthly

Executive Summary

European review documents for Oxford GlycoSciences/Actelion’s Gaucher disease treatment Zavesca raise two concerns that are likely issues in FDA’s review: comparative efficacy to enzyme replacement therapy and neurological adverse events.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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