News Category: Regulatory news
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.
Further information, including advice for patients and healthcare professionals, is available from the EMA’s website.