MS Drug Approved for Moderate-to-Severe Crohn Disease

The multiple sclerosis drug Tysabri (natalizumab) has been approved for the treatment of moderate-to-severe Crohn disease, the FDA announced Monday. The drug may be used in patients with inflammation who cannot tolerate, or have not responded to, conventional Crohn treatments.

Tysabri's label includes a boxed warning about progressive multifocal leukoencephalopathy. In addition, other adverse effects, such as anaphylaxis and liver injury, have occurred in patients on the drug. Accordingly, to help ensure that Tysabri is used safely, patients, prescribers, pharmacies, and infusion centers must be enrolled in the Tysabri Outreach Unified Commitment to Health (TOUCH) prescribing program.