EMA reconfirms the low Benefit risk profile of Zinbryta

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), in its latest review of Zinbryta, has reconfirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.

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 PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.

Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued in March 2018.

There are no immediate consequences of the PRAC’s review as Zinbryta is no longer authorised in the EU. On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine. Zinbryta is no longer available in hospitals and pharmacies in the EU.

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News Source: EMA Website

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