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