Biogen Idec Inc. and Elan Corp's Tysabri received U.S. Food and Drug Administration approval to be used in patients with moderate to severe Crohn's disease when standard drug treatments are ineffective.
Tysabri was previously FDA approved for the treatment of Multiple Sclerosis but was removed from market in 2005 after three patients using it developed the nervous disorder multifocal leukoencephalopathy (PML). Under restricted distribution the drug was allowed back on the market the following year and Biogen reports that 12,000 MS patients use it with no further reports of the fatal disorder.
Crohn's disease patients will have to enroll in a similar distribution program to receive Tysabri. The program consists of educational information regarding the drug's risks and restriction of the physicians allowed to dispense the injectable drug.
Distribution of the drug is expected to begin by the end of February and Biogen has stated that a year's supply of the medication will be priced at $29,000 for a year's supply.
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