NEJM publishes positive 2-year Tysabri data
With an FDA committee meeting looming to review the status of Tysabri, the New England Journal of Medicine published the results of two Phase III trials plus a safety evaluation that concluded the multiple sclerosis drug cut the risk of disease progression by 42 percent. Tysabri also cut the risk of relapse over a year by 68 percent. Tysabri was withdrawn from the market a year ago after three cases of a rare brain disorder called PML were reported among patients taking the drug. Two of those cases were fatal. In an accompanying editorial, the Journal noted that the risk of PML was small with brief use. A number of analysts are looking for the FDA to allow Tysabri's return, but with limited use and strict safety oversight to guard against any new cases of PML.
- here's the report from MarketWatch
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