Inebilizumab: First Approval
online resourceposted on 2020-07-30, 21:02 authored by James E. Frampton
Compliance with Ethical Standards
Funding The preparation of this review was not supported by
any external funding.
Conflict of interest During the peer review process the
manufacturer of the agent under review was offered an opportunity to comment on
the article. Changes resulting from any comments received were made by the
authors on the basis of scientific completeness and accuracy. James E. Frampton
is a salaried employee of Adis International Ltd/Springer Nature, is
responsible for the article content and declares no relevant conflicts of
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Review can be found here
Inebilizumab (Uplizna™; inebilizumab-cdon in the USA) is a humanised anti-CD19 monoclonal antibody being developed by Viela Bio for the treatment of a range of autoimmune diseases associated with CD19-expressing B cells. Inebilizumab targets and depletes CD19-expressing B cells through antibody-dependent cell-mediated cytotoxicity. In June 2020, inebilizumab received its first global approval in the USA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for immunoglobulin G autoantibodies against aquaporin-4 (AQP4-IgG). The drug is also undergoing clinical evaluation for kidney transplant desensitization, myasthenia gravis, and IgG4-related disease. This article summarizes the milestones in the development of inebilizumab leading to this first approval for the treatment of AQP4-IgG seropositive NMOSD.
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