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The Food and Drug Administration has approved the multiple sclerosis (MS) treatment Tysabri (natalizumab) for use among patients with a severe intestinal disorder in the US.
The drug, which is manufactured by Biogen Idec and Elan, has been approved for use in patients with moderate to severe Crohn’s disease who do not respond to more conventional drugs, such as Abbott Laboratories’ Humira (adalimumab).
The approval represents a reversal in fortunes for Tysabri, which was temporarily withdrawn from the market in 2005 after three patients using the drug developed a rare nervous system disorder called progressive multifocal leukoencephalopathy, or PML.
The FDA allowed the drug to return to the market the following year, but only under a restricted distribution programme.
The drug is used by more than 12,000 MS patients in the US, according to Biogen, and there have been no further reports of people suffering from PML since it was reintroduced.
Government officials said that Crohn’s disease patients will have to enrol in a similar distribution programme for Tysabri, and will have to participate in an educational scheme which will inform them of the drug’s risks.
About 500,000 people in the US have Crohn’s, which usually causes diarrhoea, fever and internal bleeding.
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