EMA review confirms risks of Abbvie and Biogen's Zinbryta outweigh benefits

The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the treatment of multiple sclerosis (MS), do not outweigh its risks, following a review carried out by the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) at the request of the European Commission.

The PRAC confirmed that the drug "poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs", and that "patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected".

The investigation followed 12 reports linking Zinbryta to cases of inflammatory brain disorders around the world such as encephalitis and meningoencephalitis, with three cases resulting in death. On 6 March, the PRAC recommended that the product be pulled from the European market, and by 27 March, Biogen and Abbvie voluntarily withdrew the drug from all markets.

Despite the fact that the review confirmed the PRAC’s original recommendation, there will be no immediate impact of the findings as Zinbryta is not currently authorised in the EU. The drug was first awarded approval in the region in 2016 for the treatment of relapsing forms of MS in adults.

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