Tysabri safety analysis
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Biogen Idec/Elan's safety analysis of its Crohn's disease and rheumatoid arthritis trials with Tysabri (natalizumab) found no new confirmed cases of progressive multifocal leukoencephalopathy, the firms state Oct. 17. The announcement follows the sponsors' earlier statement that a safety evaluation of their pivotal trials in multiple sclerosis found no new cases of PML. Biogen and Elan resubmitted Tysabri for marketing in September; a priority review has been requested (1Pharmaceutical Approvals Monthly October 2005, In Brief)...