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Tysabri for Crohn’s gets FDA advisory review

Executive Summary

FDA's Gastrointestinal Drugs and Drug Safety and Risk Management Advisory Committees will jointly review Biogen Idec/Elan's Tysabri (natalizumab) for moderately to severely active Crohn's disease July 31. Indicated for multiple sclerosis, Tysabri's sNDA includes results of three trials assessing the biologic as both an induction and maintenance therapy. Biogen pulled Tysabri from the market in 2005 after reports of progressive multifocal leukoencephalopathy, and the company is now in the second phase of the drug's relaunch. One of the three reported cases of PML in the Tysabri database was in a Crohn's patient...

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