Amid an ongoing safety review of the multiple sclerosis (MS) drug daclizumab (Zinbryta, Biogen/AbbVie), the European Medicines Agency (EMA) has restricted its use to patients who experience highly active relapsing MS despite having undergone a full and adequate course of treatment with at least one disease-modifying therapy (DMT) or patients with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs.
The EMA has also advised against using daclizumab in patients with preexisting hepatic disease or hepatic impairment and in patients with autoimmune diseases other than MS, and they urge caution when using the drug in combination with drugs that can damage the liver.
Patients whose serum transaminase levels (ALT or AST) are at least twice the upper limit of normal should not use daclizumab, they said.
The agency also recommends caution in using daclizumab in combination with medicinal products of known hepatotoxic potential, including nonprescription medicines and herbal supplements.
They recommend that clinicians continue to monitor the liver function of patients receiving daclizumab and that they watch for signs and symptoms of liver injury.
Healthcare providers should also "promptly" review any patients who are currently taking daclizumab to determine whether the drug continues to be appropriate for individual patients.
These provisional recommendations from the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) have been issued "as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing," the agency said.
PRAC's ongoing safety review was triggered following 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. Cases of liver injury with daclizumab have occurred early after starting treatment, following repeated treatment courses and several months after discontinuation, the EMA notes.
Daclizumab, given as a once-monthly injection, 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, 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.
The EMA said further details on these provisional measures will be provided in writing to healthcare professionals, and the product information will be updated accordingly. The agency will provide further information once the review is concluded.
Cite this: EMA Restricts Use of Daclizumab (Zinbryta) in MS - Medscape - Jul 07, 2017.
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