EMA Requests Immediate Recall of MS Drug Daclizumab (Zinbryta)

Megan Brooks

Disclosures

March 07, 2018

Today, the European Medicines Agency (EMA) recommended the immediate suspension and recall of the multiple sclerosis (MS) drug daclizumab (Zinbryta, Biogen/AbbVie), following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.

In a statement, the EMA said a preliminary review of the available evidence indicates that "immune reactions observed in the reported cases may be linked to the use of Zinbryta." It may also be linked to severe immune reactions affecting several other organs, the statement notes.

"To protect patients' health," EMA has called for the immediate suspension of the drug's marketing authorization in the European Union and a recall of batches from pharmacies and hospitals.

The agency advises healthcare providers not to start any new patient on daclizumab and to immediately consider alternative treatments for patients currently receiving the drug. Patients stopping treatment must be followed up for at least 6 months, the agency said.

On March 2, as reported by Medscape Medical News, Biogen and AbbVie voluntarily pulled daclizumab for relapsing MS off the market worldwide because of mounting concerns about safety, including reports of severe liver damage and immune-related conditions.

The company's announcement came the same day that the EMA announced an "urgent review" of daclizumab following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.

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