PRAC Launches Safety Review of MS Drug Daclizumab (Zinbryta)

Megan Brooks

June 09, 2017

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has launched a review of daclizumab (Zinbryta, Biogen/AbbVie), which is used to treat adults with relapsing forms of multiple sclerosis (MS).

The review follows the death from fulminant liver failure of a patient who was treated with daclizumab in an ongoing observational study, as well as four cases of serious liver injury.

"The PRAC will now evaluate all available data and determine whether there are any implications for the use of the product and if there is a need to introduce any new measures to minimize the risk of liver damage," the EMA said in a statement.

Daclizumab, given as a once-monthly injection, was first authorized for use in the European Union in 2016.

Daclizumab was approved by the US Food and Drug Administration (FDA) for relapsing forms of MS in May of last year, as reported by Medscape Medical News. The FDA cautioned, however, that the daclizumab should only be used in patients who have failed to respond to one or two prior therapies, because it carries serious safety risks, including potentially severe liver damage and immune conditions.

In the United States, daclizumab carries a boxed warning alerting clinicians that the drug can cause severe, potentially fatal, liver injury and advising that patients' liver function be tested prior to administering the first dose, before each monthly dose, and for 6 months after stopping the drug.

Daclizumab is a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 receptor subunit (CD25), which is expressed at abnormally high levels on T cells in patients with MS.

The PRAC review of daclizumab was launched at the request of the European Commission. The PRAC recommendation will be forwarded to the Committee for Medicinal Products for Human Use for the agency's final opinion.

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