Medicine to be voluntarily withdrawn from the market by the company
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.
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.
Doctors in the EU will be contacted directly in the coming days with further information. Until then EMA advises that:
- doctors should not start new patients on Zinbryta;
- doctors should review patients currently treated with Zinbryta and initiate alternative therapy, as soon as possible;
- patients must not stop their medication without discussing with their doctor;
- patients who have any questions should talk to their doctor.
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.
EMA will communicate further as necessary.