Inebilizumab: First Approval

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-depe...

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Bibliographic Details
Published in:Drugs (New York, N.Y.) N.Y.), 2020-08, Vol.80 (12), p.1259-1264
Main Author: Frampton, James E.
Format: Article
Language:English
Subjects:
AdisInsight Report
Antibodies
Antibody-dependent cell-mediated cytotoxicity
Aquaporin 4
Aquaporins
Autoantibodies
Autoimmune diseases
CD19 antigen
Cytotoxicity
Desensitization
Disease
Drug dosages
Health services
IgG antibody
Immunoglobulin G
Immunoglobulins
Internal Medicine
Kidney transplantation
Kidney transplants
Lymphocytes B
Lymphoma
Medical treatment
Medicine
Medicine & Public Health
Monoclonal antibodies
Multiple sclerosis
Myasthenia
Myasthenia gravis
Neuromuscular junctions
Neuromyelitis
Pharmacology/Toxicology
Pharmacotherapy
Plasma
Population
Toxicity
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Description
Summary: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.
ISSN:0012-6667
1179-1950
DOI:10.1007/s40265-020-01370-4