FDA Approves Tysabri as Treatment for Crohn’s Disease

The Food and Drug Administration (FDA) announced Monday it had approved Tysabri, a drug used to treat multiple sclerosis, for use in patients with moderate to severe Crohn’s disease.

However, the approval comes with a warning that the drug has the risk of causing a rare but serious brain infection.  

Crohn’s disease is a painful, serious, inflammatory bowel disease that afflicts over half a million people in the United States.   There is no known cure, and the disease typically causes intestinal bleeding, diarrhea and fever.

Tysabri (natalizumab), made by Biogen Idec Inc. and Elan Corp., was withdrawn from the market in 2005 after three patients using the drug developed progressive multifocal leukoencephalopathy, or PML, a rare but deadly viral infection in the brain.

The FDA approved the drug’s return to the market in 2006 under a restricted distribution program which remains in place today. This means Crohn’s disease patients who will be treated with Tysabri must sign up for an educational program on the drug’s risks and can only receive the Tysabri from a select number of registered physicians.

Biogen said distribution of Tysabri for Crohn’s patients would begin next month.  In the United States, the drug is expected to compete with Johnson & Johnson’s Remicade, the leading treatment for Crohn’s disease.

Company representatives told Associated Press a year’s supply of Tysabri will likely be priced at $29,000.

Tysabri is currently used by more than 12,000 multiple sclerosis patients with no new reports of PML.  Last week, Biogen executives said the company hopes to grow Tysabri’s market to 100,000 patients by 2010.   However, some analysts say the drug’s safety risks could limit its distribution.

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