MS drug given green light to re-enter the market with limits

NEWS IN BRIEF — Posted April 3, 2006

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A Food and Drug Administration Advisory panel voted unanimously March 7 to allow the multiple sclerosis drug natalizumab, or Tysabri, to re-enter the market with restrictions on its use. The drug was withdrawn a year ago after three patients developed progressive multifocal leukoencephalopathy and two died from the brain infection.

A study published in the March 2 New England Journal of Medicine found no evidence of the serious disorder in a trial of more than 3,000 people treated with Tysabri for a range of conditions that included MS, Crohn's disease and rheumatoid arthritis.

The drug was approved November 2004 to treat relapsing-remitting MS. Studies had shown it substantially reduced the frequency of relapses.

The FDA advisory committee concluded that the drug should be made available once again. The move is unusual. The only other drug allowed back on the market after safety concerns led to its withdrawal was Lotronex.

The agency will determine what restrictions should be placed on the use of Tysabri, said Robert Temple, MD, director of FDA's office of medical policy.

The drug's manufacturers pledged to work with the FDA to finalize details of a risk management plan. They said FDA action was expected by the end of March.

Note: This item originally appeared at

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