Zinbryta was approved to treat adults with relapsing multiple sclerosis (MS). Zinbryta was voluntarily withdrawn from the global market in March 2018, after the drug was tied to serious brain inflammation, including encephalitis and meningoencephalitis.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system. The condition is one of the most common causes of neurological disability in young adults. Most people experience the first symptoms of MS while in their 40s, and the disease is more common in women than men.
Relapsing MS causes episodes of worsening function (relapses) that are initially followed by recovery periods (remissions). Over time, relapsing MS can lead to progressive decline in function and increased disability.
Zinbryta (daclizumab) was approved by the U.S. Food & Drug Administration (FDA) in May 2016. The long-acting injection was designed to be self-administered by the patient on a monthly basis.
Zinbryta is a new form of a humanized monoclonal antibody and affects three different cells that regulate the immune system:
Because of its serious safety risk, the FDA cautioned that Zinbryta should generally only be used in patients who have had an inadequate response to two or more other MS treatments. Use of the drug was already highly restricted prior to the Zinbryta recall. Among other things, health care providers and patients were required to enroll in a Risk Evaluation and Mitigation Strategy (REMS) Program to ensure required liver monitoring and other safeguards.
The Zinbryta label includes a Black Box Warning – the most serious type of safety notice – regarding a risk of severe liver injury, including life-threatening and potentially fatal events. Zinbryta patients should undergo blood tests to assess liver function prior to initiating treatment, once a month prior to each dose, and monthly for 6 months once treatment has ended.
Other risks noted in the Black Box Warning include:
Additional highlighted warnings include:
In clinical trials, the most common adverse reactions experienced by Zinbryta patients include:
Biogen Inc. and AbbVie Inc. announced it would be voluntarily withdrawing Zinbryta from the global market in March 2018, after regulators in the European Union recommended that the drug be recalled.
The request came after a dozen patients taking Zinbryta developed serious inflammatory brain conditions, including encephalitis and meningoencephalitis. The cases included three patient deaths reported in the United States.
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