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The European Medicines Agency (EMA) has started an urgent review of the multiple sclerosis medicine Zinbryta (daclizumab) following 7 cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.
Biogen and AbbVie announced that Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), will be withdrawn from the market worldwide.
Zinbryta is authorised for treating relapsing forms of multiple sclerosis. Following a 2017 review of the medicine’s effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
To date over 8,000 patients have been treated with Zinbryta worldwide. The majority of EU patients have been treated in Germany.
In parallel to the start of the review, the company that markets Zinbryta (Biogen Idec Ltd) has informed EMA of its intention to voluntarily withdraw the medicine’s marketing authorisations.
The company has also informed EMA of its decision to stop ongoing clinical studies with Zinbryta in the EU. Patients in clinical studies who have any question should contact the doctor treating them in their study.
