Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed 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 On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine.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.
A full assessment report on the review will be published shortly.