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Tysabri Deaths In Crohn’s Studies Suggest "Plausible" Link – FDA Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Biogen Idec/Elan Tysabri deaths in Crohn’s trials suggest a “plausible mechanisitic link” to the monoclonal antibody, review documents state. While FDA did not note a clear connection to natalizumab, the agency found several deaths in Crohn’s disease trials to be “of concern.” Review documents do not discuss any cases of progressive multifocal leukoencephalopathy, which led to drug’s market withdrawal

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