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EMA Calls For Zinbryta's ‘Immediate’ Suspension After More Reports of Brain Disorders

 
• By Ian Schofield

Biogen/AbbVie’s Zinbryta is already being withdrawn worldwide, but EMA now wants the MS drug recalled after mounting reports of serious brain disorders.

The EMA has recommended suspending and recalling Zinbryta after 12 reports of serious brain disorders

The European Medicines Agency has formally recommended the immediate suspension and recall of all packs of Biogen’s multiple sclerosis drug Zinbryta (daclizumab beta) in the EU, saying it has now received a total of 12 reports of serious inflammatory brain disorders worldwide, of which three were fatal.

The move follows the agency’s March 2 announcement that it had begun an urgent review of the product after seven cases of such disorders were reported in Germany and one in Spain. On the same day, Biogen and its marketing partner AbbVie announced that they were voluntarily withdrawing the product’s marketing authorizations worldwide

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