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Pozelimab information


Pozelimab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetComplement C5
Clinical data
Trade namesVeopoz
Other namesREGN-3918, pozelimab-bbfg
AHFS/Drugs.comMonograph
MedlinePlusa623055
License data
  • US DailyMed: Pozelimab
Routes of
administration
Intravenous, subcutaneous
ATC code
  • None
Legal status
Legal status
  • US: WARNING[1]Rx-only[2][3]
Identifiers
CAS Number
  • 2096328-94-6
DrugBank
  • DB15218
UNII
  • 0JJ21K6L2I
KEGG
  • D11477
Chemical and physical data
FormulaC6418H9898N1690O2026S42
Molar mass144496.11 g·mol−1

Pozelimab, sold under the brand name Veopoz, is a recombinant monoclonal antibody used for the treatment of CD55-deficient protein-losing enteropathy, also known as CHAPLE disease.[2][3] Pozelimab is a complement inhibitor.[2][3] It is produced using recombinant DNA technology in Chinese hamster ovary cells.[2]

The most common adverse reactions include upper respiratory tract infections, fractures, hives, and alopecia.[3]

Pozelimab was approved for medical use in the United States in August 2023.[3][4] It is the first FDA-approved treatment for CHAPLE disease.[3][5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  2. ^ a b c d "Veopoz- pozelimab injection, solution". DailyMed. 18 August 2023. Retrieved 6 October 2023.
  3. ^ a b c d e f "FDA approves first treatment for CD55-deficient protein-losing enteropathy (CHAPLE disease)". U.S. Food and Drug Administration (FDA). 18 August 2023. Archived from the original on 19 August 2023. Retrieved 18 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "Veopoz (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease" (Press release). Regeneron Pharmaceuticals. 18 August 2023. Retrieved 18 August 2023 – via GlobeNewswire.
  5. ^ Hoy SM (November 2023). "Pozelimab: First Approval". Drugs. 83 (16): 1551–1557. doi:10.1007/s40265-023-01955-9. PMID 37856038. S2CID 264303931.
  6. ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.

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