The European Medicines Agency (EMA) has provisionally restricted the use of multiple sclerosis (MS) drug Zinbryta (daclizumab) to patients with highly active relapsing remitting MS (RRMS) that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing MS 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 conditions other than MS and caution should be used when giving Zinbryta together with medicines that can damage the liver. Doctors have been advised to continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued these provisional recommendations as a precaution and 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.
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.
Source: MS-UK (17/07/17)