Biogen and AbbVie have announced that Zinbryta (daclizumab), a treatment for relapsing multiple sclerosis (MS), will be withdrawn from the market worldwide.
As a limited number of patients are being treated with daclizumab, 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 daclizumab also carries several boxed warnings regarding hepatic injury, including autoimmune hepatitis as well as other immune-mediated disorders.
Daclizumab, 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 daclizumab was generally reserved for patients who had had an inadequate response to 2 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.
Biogen and AbbVie announce the voluntary worldwide withdrawal of marketing authorizations for Zinbryta (daclizumab) for relapsing multiple sclerosis [press release]. Biogen: Cambridge, MA. Published March 2, 2018. Accessed March 2, 2018.
This article originally appeared on MPR