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Tysabri safety review nearly complete

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biogen Idec/Elan expect to complete their safety review of Tysabri (natalizumab) by late summer and submit a safety data package to FDA by fall, Biogen Idec says Aug. 9. After Tysabri's marketing withdrawal in February, the sponsors had predicted a re-introduction in the fall. The re-launch is dependent on the final safety review and likely advisory panel consideration, according to Biogen Idec. While the safety review of Tysabri patients with multiple sclerosis is complete, Crohn's and rheumatoid arthritis trial reviews should be complete by late summer, the firm says. Based on a preliminary review of the data, "we would indicate to physicians to not include patients in the clinical trial setting or the commercial setting that have significant immune dysfunction," Biogen Idec CEO Jim Mullen noted during a same-day conference call...

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