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
License data
Routes of
administration 		Intravenous
Drug class Antineoplastic agent
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 for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults [9] [10] [6] and IgG4-RD. [11] Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells. [6]

Contents

The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain. [9] [6]

Inebilizumab was approved for medical use in the United States in June 2020, [9] [12] in the European Union in April 2022, [8] and in Canada in December 2023. [2] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. [13]

Medical uses

Inebilizumab is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). [9] [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. [9] 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. [9] 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 FDA approved the Uplizna as the first treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can affect multiple organs. [11]

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. [9] [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. [9]

Women who are pregnant should not take inebilizumab because it may cause harm to a developing fetus or newborn baby. [9] 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. [9]

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. [9]

History

Inebilizumab was created from the research led by Thomas Tedder at Cellective Therapeutics, [15] and development was continued by Viela Bio and MedImmune. [16]

Inebilizumab was approved for medical use in the United States in June 2020. [9] [12]

The effectiveness of inebilizumab for the treatment of NMOSD was demonstrated in a clinical study (NCT02200770) of 230 adult participants that evaluated the efficacy and safety of intravenous inebilizumab. [9] In the trial, 213 of the 230 participants had antibodies against AQP4 (anti-AQP4 antibody positive). [9] [12] During the 197-day study, the risk of an NMOSD 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. [9] There was no evidence of a benefit in participants who were anti-AQP4 antibody negative. [9] 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 U.S. Food and Drug Administration (FDA) granted the application for inebilizumab orphan drug designation and granted approval of Uplizna to Viela Bio. [9]

Society and culture

In November 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Uplizna, intended for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive. [17] The applicant for this medicinal product is Viela Bio. [17] Inebilizumab was approved for medical use in the European Union in April 2022. [8] [18]

Names

Inebilizumab is the international nonproprietary name (INN) and the United States Adopted Name (USAN). [19] [20]

References

  1. ↑ https://www.tga.gov.au/resources/prescription-medicines-registrations/uplizna-amgen-australia-pty-ltd [ bare URL ]
  2. 1 2 "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.
  9. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 "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 .
  10. ↑ "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.
  11. 1 2 "FDA Approves Uplizna for Chronic Inflammatory Condition IgG4-RD". Managed Healthcare Executive. 7 April 2025. Retrieved 9 April 2025.
  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 launch is a 'testament' to NC's prowess in drug R&D | WRAL TechWire". 1 July 2020. Retrieved 8 July 2020.
  16. ↑ "Viela Bio Spins Out of MedImmune". Viela Bio. 28 February 2018. Archived from the original on 27 June 2020. Retrieved 24 June 2020.
  17. 1 2 "Uplizna: Pending EC decision". European Medicines Agency. 11 November 2021. Archived from the original on 12 November 2021. Retrieved 13 November 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  18. ↑ "Uplizna Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  19. ↑ 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.
  20. ↑ "Inebilizumab" (PDF). USAN.

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