Health

Clinical trials of multiple sclerosis drug get go-ahead

NEWS IN BRIEF — Posted March 13, 2006

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The Food and Drug Administration is allowing clinical studies of the multiple sclerosis drug Tysabri, or natalizumab, to go forward, although the drug is not being placed back on the market yet.

Sales of Tysabri were halted in February 2005 after three patients developed PML, or progressive multifocal leukoencephalopathy. Two died.

The removal of the hold on clinical trials allows patients with MS who were previously treated with the drug under an investigational study to resume treatment in an IND study after discussion with their physicians about the potential risks and benefits of treatment, according to the FDA.

Tysabri had been granted accelerated approval by the FDA in 2004 because of its promise at treating flare-ups of multiple sclerosis that occur in the majority of the 400,000 patients diagnosed with this chronic disease.

An FDA advisory committee was scheduled to meet March 7 and 8 to discuss an application for marketing the drug once again.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/03/13/hlbf0313.htm.

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