Garadacimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | Coagulation factor XIIa |
| Clinical data | |
| Trade names | Andembry |
| Other names | CSL-312, garadacimab-gxii |
| AHFS/Drugs.com | andembry |
| License data |
|
| Routes of administration | Subcutaneous, |
| Drug class | Bleeding suppressant |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Garadacimab, sold under the brand name Andembry, is a human monoclonal antibody used for the treatment of hereditary angioedema.[5][6] Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.[8][9]
Garadacimab is a fully human, recombinant, IgG4 lambda monoclonal antibody that binds to the catalytic domain of activated factor XII (FXIIa).[6] FXIIa is the first factor activated in the contact system, which leads to the production of bradykinin.[6] 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.[6]
Garadacimab was authorized for medical use in the European Union in February 2025,[6][7] and approved in the United States in June 2025.[10][11]
Medical uses
[edit]Garadacimab is indicated for routine prevention of recurrent attacks of hereditary angioedema in people aged twelve years of age and older.[6][7]
Society and culture
[edit]Legal status
[edit]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.[6] The applicant for this medicinal product is CSL Behring GmbH.[6] Garadacimab was designated an orphan medicine by the EMA.[6] Garadacimab was authorized for medical use in the European Union in February 2025.[6][7]
Garadacimab was approved for medical use in the United States in June 2025.[10][12]
Names
[edit]Garadacimab is the international nonproprietary name.[13]
Garadacimab is sold under the brand name Andembry.[6][7]
References
[edit]- ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/andembry-csl-behring-australia-pty-ltd [bare URL]
- ^ https://www.tga.gov.au/resources/artg/443611 [bare URL]
- ^ https://www.tga.gov.au/resources/artg/428253 [bare URL]
- ^ "Andembry 200 mg Solution for injection in pre-filled pen". (emc). 11 March 2025. Retrieved 12 March 2025.
- ^ a b https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761367s000lbl.pdf [bare URL PDF]
- ^ a b c d e f g h i j k l "Andembry EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 13 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b c d e "Andembry PI". Union Register of medicinal products. 12 February 2025. Retrieved 16 February 2025.
- ^ "Garadacimab (Code C166633)". NCI Thesaurus. 25 November 2024. Retrieved 13 December 2024.
This article incorporates text from this source, which is in the public domain.
- ^ Cohn DM, Renné T (October 2024). "Targeting factor XIIa for therapeutic interference with hereditary angioedema". Journal of Internal Medicine. 296 (4): 311–326. doi:10.1111/joim.20008. PMID 39331688.
- ^ a b "Novel Drug Approvals for 2025". U.S. Food and Drug Administration (FDA). 17 June 2025. Retrieved 20 June 2025.
- ^ https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761367Orig1s000ltr.pdf [bare URL PDF]
- ^ "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. Retrieved 19 June 2025 – via PR Newswire.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.
External links
[edit]- Clinical trial number NCT04656418 for "CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks" at ClinicalTrials.gov
