The European Medicines Agency has restricted the use of Zinbryta (daclizumab) for relapsing multiple sclerosis after reports of patients experiencing severe liver damage and one dying of liver disease.
The temporary order restricts Zinbryta to European Union patients with a highly active disease who have failed to respond to other disease-modifying therapies, and patients with a rapidly evolving disease who cannot be treated with other disease-modifying drugs.
The U.S. Federal Drug Administration, which like European regulators is aware that Zinbryta can be toxic to the liver, has yet to restrict its use.
Patients with liver damage should not take Zinbryta under any circumstances. The same applies to those with another autoimmune disease in addition to MS.
The agency’s Pharmacovigilance Risk Assessment Committee asked for the restrictions after learning about the death of a patient enrolled in an ongoing observational study of Zinbryta. The patient died of liver failure. Four patients developed severe liver damage.
The liver injuries occurred at different times in the treatment course. The range was from early in the treatment to several months after a patient stopped taking the medication.
The risk assessment committee said its recommendation was aimed at ensuring that Zinbryta is used in the safest way possible while researchers review its safety. When the review is finished, both patients and doctors will receive more information, it added.
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