Tysabri Could Return To Market As “Niche” Drug, Analyst Says
This article was originally published in The Pink Sheet Daily
Morgan Stanley report predicts sales of $500 mil. for Biogen Idec/Elan’s multiple sclerosis therapy if it returns to market. Analyst’s review shows additional safety signals.
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Biogen Idec and Elan will complete a Tysabri safety review by late summer in the hopes of bringing the multiple sclerosis therapy back on the market.
Company plans to issue revised guidance in May after warning investors not to rely on previous financial forecasts. Announcement coincides with news that a third diagnosis of PML was discovered in a clinical trial for Tysabri.
One fatal, confirmed case of progressive multifocal leukoencephalopathy and one suspected case prompt withdrawal of multiple sclerosis product; risk/benefit ratio needs to be reestablished, companies say. Return to market would not be unprecedented, but Tysabri’s withdrawal sharpens focus on FDA's drug safety oversight.