Evidence indicates risk of serious inflammatory brain disorders
The European Medicines Agency (EMA) has recommended the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.
A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune reactions affecting several other organs.
To protect patients’ health, EMA is recommending the immediate suspension of the medicine‘s marketing authorisation in the EU and a recall of batches from pharmacies and hospitals.
No new patients should start treatment with Zinbryta. Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6 months (see more details below).
EMA’s recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision.
The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine’s marketing authorisation and informed EMA of its intention to stop clinical studies.