Zinbryta to be used in restricted patient group, with strict liver monitoring
The European Medicines Agency (EMA) has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.
The review found that unpredictable and potentially fatal immune-mediated liver injury can occur during treatment with Zinbryta and for up to 6 months after stopping treatment. In clinical trials, 1.7% of patients receiving Zinbryta had a serious liver reaction.
Zinbryta should now only be used in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with any other DMTs. Details of the recommendations for patients and healthcare professionals are given below.
The review of the liver effects of Zinbryta was conducted by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which issued recommendations in October 2017.
The Committee for Medicinal Products for Human Use has now adopted EMA’s final opinion, which will be sent to the European Commission for adoption of a legally binding decision.