FDAnews Drug Daily Bulletin

EMA Seeks Zinbryta Recall After Reports of Brain Inflammation and Death

March 9, 2018

The European Medicines Agency called for the immediate suspension and recall of Biogen’s multiple sclerosis drug Zinbryta (daclizumab) following a review of 12 reports of serious inflammatory brain disorders, three of which were fatal.

Biogen voluntarily requested the drug’s withdrawal and announced its intention to stop clinical studies of the product.

The EMA sent its recommendation to the European Commission for a legally binding decision.

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