Inebilizumab

Inebilizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCD19
Clinical data
Pronunciation/ɪˌnɛbɪˈlɪzjʊmæb/
ih-NEH-bih-LIZ-yuum-ab
Trade namesUplizna
Other namesMEDI-551, inebilizumab-cdon
AHFS/Drugs.comMonograph
License data
Routes of
administration		Intravenous
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • None
UNII
KEGG
Chemical and physical data
FormulaC6504H10080N1732O2044S44
Molar mass146652.90 g·mol−1

Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults.[8][9][5] Inebilizumab is a humanized mAb that binds to and depletes CD19+ B cells including plasmablasts and plasma cells.[5]

The most common adverse reactions include urinary tract infection, headache, joint pain (arthralgia), nausea and back pain.[8][5]

Inebilizumab was approved for medical use in the United States in June 2020,[8][10] in the European Union in April 2022,[7] and in Canada in December 2023.[1] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[11]

  1. ^ a b "Uplizna Product information". Health Canada. 22 October 2009. Retrieved 3 March 2024.
  2. ^ "Summary Basis of Decision for Uplizna". Health Canada. 24 July 2024. Retrieved 12 October 2024.
  3. ^ "Details for: Uplizna". Health Canada. 15 December 2023. Retrieved 3 March 2024.
  4. ^ "Regulatory Decision Summary for Uplizna". Drug and Health Products Portal. 15 December 2023. Retrieved 2 April 2024.
  5. ^ a b c d Cite error: The named reference Uplizna FDA label was invoked but never defined (see the help page).
  6. ^ "Uplizna- inebilizumab injection". DailyMed. 27 July 2021. Retrieved 3 March 2023.
  7. ^ a b Cite error: The named reference Uplizna EPAR was invoked but never defined (see the help page).
  8. ^ a b c "FDA Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal Cord". U.S. Food and Drug Administration (FDA) (Press release). 11 June 2020. Retrieved 12 June 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ "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.
  10. ^ Cite error: The named reference FDA snapshot was invoked but never defined (see the help page).
  11. ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Retrieved 17 January 2021. Public Domain This article incorporates text from this source, which is in the public domain.