FDA extends Tysabri review

Biogen Idec Corp. of Cambridge and Elan Corp. PLC announced today that the US Food and Drug Administration has informed them that it requires additional time to review their Tysabri application to treat Crohn's disease.

Crohn's disease is an inflammatory disorder of the bowel; Tysabri has already been approved as a multiple sclerosis drug.

Today Biogen and Elan of Ireland said that the FDA will extend its regulatory review of Tysabri as a treatment for Crohn's disease by up to three months.

Tysabri was initially approved in the US as a multiple sclerosis drug in late 2004, but was temporarily removed from the market after it was linked in a handful of cases to a rare brain disease; the drug went back on sale in mid 2006 after an extensive safety review.

On Friday, a number of news organizations, including The Boston Globe, reported that Biogen, the state's largest biotech company, may be up for sale.
(By Chris Reidy, Globe staff)