FDA postpones Tysabri decision.

On March 22, Biogen Idec and Elan Pharmaceuticals, Inc., announced that the Food and Drug Administration (FDA) extended its review of Tysabri for up to 90 days. This may push announcement of a decision to June 28, 2006. According to Biogen and Elan, the FDA needs more time to evaluate the companies' proposed risk management plan.

Tysabri was withdrawn from the market as a therapy for relapsing MS in February 2005 after three people who had been taking the drug in clinical trials developed PML, a rare and often fatal brain disease. Since then, Biogen and Elan have conducted safety reviews of most of the 3,000 people involved in Tysabri trials for MS, Crohn's disease, and rheumatoid arthritis.

In November 2005, the FDA agreed to conduct a "priority review." And on March 8, 2006, the FDA's Advisory Committee unanimously recommended that Tysabri be returned to the market. While the FDA is not required to follow the recommendations of its advisory committee, it usually does.

"The National MS Society has been working since 1946 to give people with MS more choices for safe and effective treatments," John Richert, MD, vice president of Research and Clinical Programs for the Society, told InsideMS. "The news of this delay is disappointing. But if the FDA needs to further review the Tysabri risk management plan, it's important they take the extra time to do it thoroughly."

For the most current news, consult the Society's Web site, nationalmssociety.org/tysabri, or call your chapter at 1-800-FIGHT-MS.