Tysabri for Crohn's disease granted approval with restrictions

January 16, 2008

Natalizumab approved for Crohn's Disease

Biologic natalizumab (Tysabri, Biogen Idec/Elan) has been approved by the FDA to treat moderate to severe Crohn's disease (CD). The therapy was previously approved in 2006 for certain types of multiple sclerosis. Specifically, the new indication is for patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies. Patients who use the biologic must enroll in the Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD TOUCH), a special restricted distribution program. Due to the risk of serious adverse events with Tysabri use, including progressive multifocal leukoencephalopathy (PML) and hypersensitivity reactions, prescribers, pharmacies, and infusion centers must also be enrolled in CD-TOUCH. As part of the program, healthcare providers must evaluate CD patients after three months of therapy to determine if their condition has improved on natalizumab. If not, patients should discontinue treatment.

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