Restrictions are provisional measures while review of liver safety is ongoing
The European Medicines Agency (EMA) 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.
In addition, patients with liver injury must not be given the medicine. Starting treatment with Zinbryta is not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving Zinbryta together with medicines that can damage the liver. Doctors should continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury.
These are provisional recommendations that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.
This medicine was authorised in the EU in July 2016 to treat adults with relapsing forms of multiple sclerosis (a disease in which inflammation damages the protective sheath around the nerve cells in the brain and spinal cord).
The review of Zinbryta started after the death from liver injury (fulminant liver failure) of a patient involved in an ongoing observational study, as well as four cases of serious liver injury. The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Healthcare professionals will be informed in writing about the provisional measures to be followed by doctors. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.