Because of the risk for liver damage, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended further restrictions on daclizumab (Zinbryta, Biogen/AbbVie), used to treat adults with relapsing forms of multiple sclerosis (MS).
A safety review by the committee found that "unpredictable and potentially fatal immune-mediated liver injury" can occur during treatment with daclizumab and for up to 6 months after discontinuation of the drug, the PRAC said today.
"In order to reduce the risks, doctors should now only prescribe Zinbryta for relapsing forms of multiple sclerosis in patients who have had an inadequate response to at least two disease modifying therapies (DMTs) and cannot be treated with other DMTs," the PRAC advised.
The committee launched a safety review of daclizumab back in June following the death from fulminant liver failure of a patient who was treated with daclizumab in an ongoing observational study, as well as the occurrence of four cases of serious liver injury.
One month later, amid their ongoing review, the PRAC issued provisional recommendations restricting use of the drug to patients who experience highly active relapsing MS despite having undergone a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs.
Today, the PRAC adopted final measures aimed to improve liver monitoring and limit use of daclizumab to patients who have had an inadequate response to at least two DMTs and cannot be treated with other such therapies.
Daclizumab, given as a once-monthly injection for adults with relapsing forms of MS, was first authorized for use in the European Union in July 2016.
Daclizumab was approved by the US Food and Drug Administration (FDA) for relapsing forms of MS in May 2016. The FDA cautioned, however, that daclizumab should be used only in patients who have not responded to one or two prior therapies because it carries serious safety risks, including potentially severe liver damage and immune conditions. In clinical trials, 1.7% of patients treated with daclizumab had a serious liver reaction.
font: Medscape
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