FDA clears Tysabri for Crohn's

Call it the comeback kid. Tysabri nabbed a new indication from the FDA yesterday, as a second-line treatment for the intestinal disorder Crohn's disease. Made by Biogen Idec and Elan, Tysabri is already marketed for use in multiple sclerosis.

You'll recall that Tysabri was pulled from the market in 2005 after three patients developed multifocal leukoencephalopathy, a rare nervous system disorder. It was only allowed back on the market in 2006 under a restricted distribution program. Since then, the drug has built up a following of 12,000 MS patients in the U.S., Biogen says, with no new reports of the deadly disorder.

Tysabri will be distributed under a similar program for Crohn's patients, who'll have to take classes on its risks and receive injections only from selected doctors. An incurable intestinal disorder, Crohn's affects about 500,000 people in the U.S.--a big new market for Tysabri. Indeed, Biogen says it hopes to attract a total of 100,00 patients to the drug by 2010. That would give Tysabri annual sales of $670 million. Not quite a blockbuster, but pretty good for a product that once faced extinction.

- see the release from Biogen Idec
- read the article in the New York Times

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Tysabri: The comeback kid. Report
FDA committee backs Tysabri for Crohn's. Report
After reintroduction, Tysabri builds patient base. Report
FDA allows Tysabri back on market. Report