An FDA advisory panel voted 12-3 in favor of recommending Biogen IDEC and Elan's Tysabri for use in Crohn's disease patients, based on the drug's performance in clinical trials.
The agency isn't required to follow the recommendations of its advisory panels but usually does.
Tysabri, originally approved as a multiple sclerosis (MS) treatment, was pulled off the US market in February 2005, after three patients developed a rare and potentially deadly brain infection.
That FDA allowed Tysabri back on the market in June 2006 under a restricted distribution program dubbed the “Tysabri Outreach: Unified Commitment to Health (TOUCH) prescribing program.”
Before Tysabri treatment can start, patients must undergo a magnetic resonance imaging scan. Then, patients on Tysabri are to be evaluated at three and six months after the first infusion, and every six months after that, with their status being reported directly to Biogen IDEC.
An estimated 14,000 patients across the globe are currently taking Tysabri for MS, a year after the drug's return to market. In the US, over 8,600 patients are on Tysabri and over 1,800 physicians have prescribed the therapy. In the European Union, over 4,300 patients are on Tysabri therapy. An additional 1,000 patients are taking the drug in global clinical trials.
Biogen, of Cambridge, MA and Dublin, Ireland-based Elan, now hope to market Tysabri to the 600,000 Crohn's patients in the US under a restrictive program similar to TOUCH.