Multiple Sclerosis Drug Being Pulled from the Market
As a limited number of patients are being treated with Zinbryta, the Companies believed it would be difficult to characterize the benefit/risk profile of the drug given the nature and complexity of adverse events being reported, including inflammatory encephalitis and meningoencephalitis cases in Europe. The labeling for Zinbryta also carries several boxed warnings regarding hepatic injury, including autoimmune hepatitis as well as other immune-mediated disorders.
Zinbryta, an interleukin-2 (IL-2) receptor blocking antibody, was approved in May 2016 to treat adults with relapsing forms of MS. Because of its safety profile, the use of Zinbryta was generally reserved for patients who had had an inadequate response to two or more drugs indicated for the treatment of MS. Its mechanism of action was presumed to involve modulation of IL-2 mediated activation of lymphocytes through binding to CD25, a subunit of the high-affinity IL-2 receptor.
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