MedPath

Inebilizumab

Generic Name
Inebilizumab
Brand Names
Uplizna 3 Vial Kit, Uplizna
Drug Type
Biotech
CAS Number
1299440-37-1
Unique Ingredient Identifier
74T7185BMM

Overview

Inappropriate growth of or self-directed antibody production by B-cells is the etiological underpinning of a variety of conditions, including the multiple sclerosis-like neurological condition neuromyelitis optica spectrum disorder (NMOSD). Inebilizumab is a humanized afucosylated monoclonal IgG1 antibody directed against the broadly expressed B-cell surface antigen CD19. Inebilizumab is cytolytic, resulting in B-cell depletion and offering therapeutic benefit to patients suffering from NMOSD. Compared to the anti-CD20 antibody rituximab, which is also used to treat NMOSD, inebilizumab has broader specificity. Inebilizumab was granted FDA approval on June 11, 2020, for the treatment of anti-aquaporin 4 positive NMOSD patients. Given its mechanism of action and good safety profile, it may prove useful in the treatment of other conditions linked to autoimmune antibody production or B-cell malignancies.

Background

Inappropriate growth of or self-directed antibody production by B-cells is the etiological underpinning of a variety of conditions, including the multiple sclerosis-like neurological condition neuromyelitis optica spectrum disorder (NMOSD). Inebilizumab is a humanized afucosylated monoclonal IgG1 antibody directed against the broadly expressed B-cell surface antigen CD19. Inebilizumab is cytolytic, resulting in B-cell depletion and offering therapeutic benefit to patients suffering from NMOSD. Compared to the anti-CD20 antibody rituximab, which is also used to treat NMOSD, inebilizumab has broader specificity. Inebilizumab was granted FDA approval on June 11, 2020, for the treatment of anti-aquaporin 4 positive NMOSD patients. Given its mechanism of action and good safety profile, it may prove useful in the treatment of other conditions linked to autoimmune antibody production or B-cell malignancies.

Indication

Inebilizumab is indicated for the treatment of aquaporin-4 (AQP4) immunoglobulin-positive (AQP4-IgG) neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

Associated Conditions

  • Neuromyelitis Optica Spectrum Disorders

FDA Approved Products

UPLIZNA
Manufacturer:Horizon Therapeutics USA, Inc.
Route:INTRAVENOUS
Strength:10 mg in 1 mL
Approved: 2021/07/27
NDC:75987-150
UPLIZNA
Manufacturer:Viela Bio, Inc.
Route:INTRAVENOUS
Strength:10 mg in 1 mL
Approved: 2020/12/23
NDC:72677-551

Singapore Approved Products

No Singapore products found for this drug

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath