FDA Panels to Review Biogen Idec’s Tysabri

Biogen Idec said Tuesday two U.S. Food and Drug Administration advisory panels will review Tysabri for treatment of Crohn’s disease July 31.

The gastrointestinal drugs advisory committee and the drug safety and risk management advisory committee will jointly review the biologic. Tysabri, which is currently indicated for treating relapsing forms of multiple sclerosis, was temporarily taken off the market in 2005 because it can increase the risk of a deadly brain infection called progressive multifocal leukoencephalopathy.

Tysabri, which Biogen co-markets with Elan, is only available in the United States through a restricted distribution program, and the companies submitted a risk management plan as part of their biologics license application for the Crohn’s disease indication.

The application is supported by three trials — ENCORE, ENACT-1 and ENACT-2 — that involved more than 1,500 patients with Crohn’s disease.