EMA confirms further restrictions on Zinbryta
The European Medicines Agency has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage, the EMA announced on Friday.
Zinbryta is a once-monthly, self-administered, subcutaneous injection and is marketed by US firms Biogen (Nasdaq: BIIB) and AbbVie (NYSE: ABBV).
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to six months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
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