EMA/PRAC recommends further restrictions for MS drug Zinbryta due to liver damage risk
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver.
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta, from US biotech firms Biogen (Nasdaq: BIIB) and AbbVie (NYSE: ABBV), and for up to six months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
In order to reduce the risks, doctors should now only prescribe Zinbryta for relapsing forms of multiple sclerosis in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with other DMTs.
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