Biogen and AbbVie have announced that they will be removing Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), from the market due to growing concerns about the drug’s safety.
According to Medscape, the drug has been linked to reports of severe liver damage and immune-related conditions.
The announcement on the withdrawal came the same day that the European Medicines Agency (EMA) announced it would be conducting an “urgent review” of Zinbryta (daclizumab) in reaction to seven cases of serious inflammatory brain disorders in Germany and one case in Spain.
Biogen and AbbVie stated that the nature and complexity of the adverse events made it impossible to accurately characterize Zinbryta’s benefit/risk profile. Both companies felt the market withdrawal would be in patients’ best interests.
Zinbryta was approved in the U.S. in May 2016; however, with the approval, the Food and Drug Administration (FDA) recommended the drug only be used in patients who have not responded to prior therapies.
The following adverse events have been associated with Zinbryta:
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