Inebilizumab: First Approval
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ADISINSIGHT REPORT
Inebilizumab: First Approval James E. Frampton1
© Springer Nature Switzerland AG 2020
Abstract 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. Inebilizumab (Uplizna™): Key points A humanized anti-CD19 monoclonal antibody being developed by Viela Bio for the treatment of NMOSD, kidney transplant desensitization, myasthenia gravis and IgG4-related disease Received its first approval on 11 June 2020 in the USA Approved for the treatment of NMOSD in adult patients who are AQP4-IgG seropositive
1 Introduction Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune, demyelinating disease of the CNS now recognized to be distinct from multiple sclerosis [1]. This Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.12660503. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * James E. Frampton [email protected] 1
Springer Nature, Mairangi Bay, Private Bag 65901, Auckland 0754, New Zealand
relatively rare and potentially life-threatening disorder is typically characterized by incomplete recovery from recurrent attacks of optic neuritis and/or transverse myelitis, resulting in accumulating impairment (e.g. blindness and paraplegia) [1–3]. B cells appear to play a prominent role in the immunopathogenesis of NMOSD [4]; ≈ 75–90% of those with the disease have pathogenic immunoglobulin G (IgG) autoantibodies against aquaporin-4 (AQP4), the most abundant water channel in the CNS, detectable in their serum [5]. Inebilizumab (Uplizna™; inebilizumab-cdon in the USA), a humanised, affinity-optimised, afucosylated IgG1 kappa monoclonal antibody that binds to the B-cell surface antigen CD19, is being developed by Viela Bio for the treatment of a range of autoimmune diseases associated with CD19-expressing B cells [6]. Inebilizumab received its first global approval on 11 June 2020 in the USA [7], for the treatment of NMOSD in adult patients who are seropositive for IgG autoantibodies against AQP4. The recommended initial dose is two single 300 mg intravenous
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