Chemistry:Garadacimab

From HandWiki

Garadacimab, sold under the brand name Andembry, is a human monoclonal antibody used for the treatment of hereditary angioedema.[1][2] Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.[3][4]

Garadacimab is a fully human, recombinant, IgG4 lambda monoclonal antibody that binds to the catalytic domain of activated factor XII (FXIIa).[2] FXIIa is the first factor activated in the contact system, which leads to the production of bradykinin.[2] The inhibition of FXIIa therefore prevents the activation of prekallikrein into kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in attacks of hereditary angioedema.[2]

Garadacimab was authorized for medical use in the European Union in February 2025,[2][5] and approved in the United States in June 2025.[6][7] The US Food and Drug Administration considers it to be a first-in-class medication.[8][9]

Medical uses

Garadacimab is indicated for routine prevention of recurrent attacks of hereditary angioedema in people aged twelve years of age and older.[2][5]

Society and culture

In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Andembry, intended for the prevention of recurrent attacks of hereditary angioedema.[2] The applicant for this medicinal product is CSL Behring GmbH.[2] Garadacimab was designated an orphan medicine by the EMA.[2] Garadacimab was authorized for medical use in the European Union in February 2025.[2][5]

Garadacimab was approved for medical use in the United States in June 2025.[6][10]

Names

Garadacimab is the international nonproprietary name.[11]

Garadacimab is sold under the brand name Andembry.[2][5]

References

  1. ↑ Cite error: Invalid <ref> tag; no text was provided for refs named Andembry FDA label
  2. ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "Andembry EPAR". 12 December 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/andembry.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. ↑ "Garadacimab (Code C166633)". 25 November 2024. https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C166633.  Public Domain This article incorporates text from this source, which is in the public domain.
  4. ↑ "Targeting factor XIIa for therapeutic interference with hereditary angioedema". Journal of Internal Medicine 296 (4): 311–326. October 2024. doi:10.1111/joim.20008. PMID 39331688. 
  5. ↑ 5.0 5.1 5.2 5.3 "Andembry PI". 12 February 2025. https://ec.europa.eu/health/documents/community-register/html/h1885.htm. 
  6. ↑ 6.0 6.1 "Novel Drug Approvals for 2025". 17 June 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. 
  7. ↑ "BLA Approval". https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761367Orig1s000ltr.pdf. 
  8. ↑ "Novel Drug Approvals for 2025". 8 July 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. 
  9. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (PDF). January 2026. https://www.fda.gov/media/190705/download. 
  10. ↑ "U.S. Food and Drug Administration Approves CSL's Andembry (garadacimab-gxii), the Only Prophylactic Hereditary Angioedema (HAE) Treatment Targeting Factor XIIa with Once-Monthly Dosing for All Patients From the Start" (Press release). CSL. 16 June 2025. Archived from the original on 18 June 2025. Retrieved 19 June 2025 – via PR Newswire.
  11. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information 33 (3). 2019. 

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