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news.An advisory panel to the FDA has voted unanimously in favor of the reinstatement of Biogen Idec and Elan Corporation's multiple sclerosis treatment, Tysabri.
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All 12 members of the panel recommended that Tysabri should be re-launched with warnings about the safety concerns associated with the drug.
The drug was pulled from the market a year ago having been available for only three months before two patients using the drug were found to have contracted an extremely rare but deadly brain disease known as progressive multifocal leukoencephalopathy (PML).
An extensive safety review conducted by the companies in the light of the safety concerns now seems to have brought Tysabri within touching distance of a return to market. Should the drug ultimately be re-approved by the FDA, analysts predict that its sales could top $1 billion per year.
The eventual FDA decision, expected by the end of March, will take into account the appeals of patients with multiple sclerosis who would like to be given the choice as to whether to risk the possible side effects.