FDAnews Drug Daily Bulletin

EMA’s PRAC Recommends Restricting Zinbryta Use to Certain MS Patients

July 20, 2017

The European Medicines Agency is provisionally restricting the use of the multiple sclerosis medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.

Patients with liver injury must not be given the medicine, according to the EMA’s Pharmacovigilance Risk Assessment Committee, which said a review of its liver safety is ongoing.

Developed by Biogen, Zinbryta was authorized in July 2016. The review began after one patient in an ongoing observational study died from fulminant liver failure, and there were four additional cases of serious liver injury.

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