Inebilizumab

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Inebilizumab
Monoclonal antibody
Type Whole antibody
Source Humanized
Target CD19
Clinical data
Pronunciation /ɪˌnɛbɪˈlɪzjʊmæb/
ih-NEH-bih-LIZ-yuum-ab
Trade names Uplizna
Other namesinebilizumab-cdon, AMG 335, HZN-551, VIB-551, MEDI-551
AHFS/Drugs.com Monograph
MedlinePlus a625074
License data
Routes of
administration 		Intravenous
Drug class Immunosuppressive drug
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
Chemical and physical data
Formula C6504H10080N1732O2044S44
Molar mass 146652.90 g·mol−1

Inebilizumab, sold under the brand name Uplizna, is a medication used for the treatment of neuromyelitis optica spectrum disorder, immunoglobulin G4-related disease, and generalized myasthenia gravis. [6] [10] Inebilizumab is a humanized monoclonal antibody that binds to and depletes CD19+ B cells including plasmablasts and plasma cells (a CD19-directed cytolytic antibody). [6]

Contents

The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. [11] [6]

Inebilizumab was approved for medical use in the United States in June 2020, [11] [12] in the European Union in April 2022, [8] and in Canada in December 2023. [2] The US Food and Drug Administration considers it to be a first-in-class medication. [13]

Medical uses

Inebilizumab is indicated indicated for the treatment of neuromyelitis optica spectrum disorder in adults who are anti-aquaporin-4 antibody positive; and for the treatment of immunoglobulin G4-related disease in adults. [6]

Neuromyelitis optica spectrum disorder is a rare autoimmune disorder in which immune system cells and autoantibodies attack and damage the optic nerves and spinal cord. [11] Neuromyelitis optica spectrum disorder can be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antibody appears to activate other components of the immune system, causing inflammation and damage to the central nervous system. [11] Clinically, the disease is manifested with attacks/relapses that result in neurological impairment such as blindness, paraplegia, sensory loss, bladder dysfunction, and peripheral pain. The disability from each attack is cumulative, making neuromyelitis optica spectrum disorder a chronically debilitating and potentially life-threatening disease. [14]

In April 2025, the US Food and Drug Administration approved inebilizumab as the first treatment for adults living with immunoglobulin G4-related disease, a chronic inflammatory condition that can affect multiple organs. [15]

In September 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended extending the therapeutic indication of inebilizumab, a medicine used to treat adults with neuromyelitis optica spectrum disorders, to include the treatment of active immunoglobulin G4-related disease, a rare autoimmune disease for which there are no authorized medicines in the EU. [16]

In December 2025, the US FDA approved inebilizumab for adults with generalized myasthenia gravis. [10]

Side effects

The label for inebilizumab includes a warning for infusion reactions, potential depletion of certain proteins (hypogammaglobulinemia), and potential increased risk of infection — including progressive multifocal leukoencephalopathy, and potential reactivation of hepatitis B and tuberculosis. [11] [6]

The most common adverse reactions in the neuromyelitis optica spectrum disorder clinical trial were urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. [11]

Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby. [11] The FDA advises health care professionals to inform females of reproductive age to use effective contraception during treatment with inebilizumab and for six months after the last dose. [11]

Vaccination with live-attenuated or live vaccines is not recommended during treatment and should be administered at least four weeks prior to initiation of inebilizumab. [11]

History

Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics, [17] and development was continued by Viela Bio and MedImmune. [18]

Inebilizumab was approved for medical use in the United States in June 2020. [11] [12]

The effectiveness of inebilizumab for the treatment of neuromyelitis optica spectrum disorder was demonstrated in a clinical study (NCT02200770) of 230 adult participants that evaluated the efficacy and safety of intravenous inebilizumab. [11] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive). [11] [12] During the 197-day study, the risk of an neuromyelitis optica spectrum disorder relapse in the 161 anti-AQP4 antibody positive participants who were treated with inebilizumab was reduced by 77% when compared to the placebo treatment group. [11] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative. [11] The primary efficacy endpoint was the time to the onset of the first adjudicated relapse on or before study day 197 evaluated by a blinded, independent, adjudication committee, who determined whether the attack met protocol-defined criteria. [12] The trial was conducted at 82 sites in 24 countries (including the United States) in North and South America, Europe, Africa, Asia and Australia. [12]

The US Food and Drug Administration granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio. [11]

Society and culture

Inebilizumab was approved for medical use in the United States in June 2020. [11] [19]

Inebilizumab was authorized for medical use in the European Union in April 2022, [8] [9] and in Canada in December 2023. [2]

Names

Inebilizumab is the international nonproprietary name and the United States Adopted Name. [20] [21]

References

  1. ↑ "Uplizna (Amgen Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 24 July 2025. Retrieved 28 September 2025.
  2. 1 2 3 "Uplizna Product information". Health Canada . 22 October 2009. Retrieved 3 March 2024.
  3. ↑ "Summary Basis of Decision for Uplizna". Health Canada . 24 July 2024. Retrieved 12 October 2024.
  4. ↑ "Details for: Uplizna". Health Canada . 15 December 2023. Retrieved 3 March 2024.
  5. ↑ "Regulatory Decision Summary for Uplizna". Drug and Health Products Portal. 15 December 2023. Retrieved 2 April 2024.
  6. 1 2 3 4 5 6 "Uplizna- inebilizumab injection". DailyMed. 8 July 2019. Retrieved 13 June 2020.
  7. ↑ "Uplizna- inebilizumab injection". DailyMed. 27 July 2021. Retrieved 3 March 2023.
  8. 1 2 3 "Uplizna EPAR". European Medicines Agency. 11 November 2021. Retrieved 4 March 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. 1 2 "Uplizna Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  10. 1 2 Amgen. "FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS". www.prnewswire.com. Retrieved 13 December 2025.
  11. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 "FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord". U.S. Food and Drug Administration (FDA) (Press release). 11 June 2020. Archived from the original on 13 June 2020. Retrieved 12 June 2020.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. 1 2 3 4 5 "Drug Trials Snapshots: Uplizna". U.S. Food and Drug Administration (FDA). 11 June 2010. Retrieved 24 June 2020.[ dead link ]PD-icon.svg This article incorporates text from this source, which is in the public domain .
  13. ↑ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  14. ↑ "Portfolio". Viela Bio. Archived from the original on 15 November 2018. Retrieved 14 November 2018.
  15. ↑ "Uplizna (inebilizumab-cdon) Is Now The First And Only FDA-approved Treatment For Igg4-related Disease" (Press release). Amgen. 3 April 2025. Retrieved 28 September 2025– via PR Newswire.
  16. ↑ "First treatment recommended for rare immunoglobulin-related autoimmune disease". European Medicines Agency (EMA) (Press release). 19 September 2025. Retrieved 28 September 2025.
  17. ↑ "Uplizna launch is a 'testament' to NC's prowess in drug R&D". WRAL TechWire. 1 July 2020. Retrieved 8 July 2020.
  18. ↑ "Viela Bio Spins Out of MedImmune". Viela Bio. 28 February 2018. Archived from the original on 27 June 2020. Retrieved 24 June 2020.
  19. ↑ "Viela Bio Announces U.S. FDA Approval of Uplizna (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)". Viela Bio (Press release). 11 June 2020. Retrieved 12 June 2020– via GlobeNewswire.
  20. ↑ World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 75". WHO Drug Information. 30 (1). hdl: 10665/331046 . License: CC BY-NC-SA 3.0 IGO.
  21. ↑ "Inebilizumab". AMA Finder.

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