Garadacimab
Medication
From Wikipedia, the free encyclopedia
Garadacimab, sold under the brand name Andembry, is a human monoclonal antibody used for the treatment of hereditary angioedema.[6][7] Garadacimab is a monoclonal antibody against the activated coagulation factor XIIa (FXIIa), with potential anti-inflammatory and anticoagulant activities.[9][10]
| 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 | Monograph |
| MedlinePlus | a625083 |
| License data |
|
| Routes of administration | Subcutaneous |
| Drug class | Bleeding suppressant |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6470H10004N1724O2022S42 |
| Molar mass | 145639.77 g·mol−1 |
Garadacimab is a fully human, recombinant, IgG4 lambda monoclonal antibody that binds to the catalytic domain of activated factor XII (FXIIa).[7] FXIIa is the first factor activated in the contact system, which leads to the production of bradykinin.[7] 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.[7]
Garadacimab was authorized for medical use in the European Union in February 2025,[7][8] and approved in the United States in June 2025.[11][12]
Medical uses
Garadacimab is indicated for routine prevention of recurrent attacks of hereditary angioedema in people aged twelve years of age and older.[7][8]
Society and culture
Legal status
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.[7] The applicant for this medicinal product is CSL Behring GmbH.[7] Garadacimab was designated an orphan medicine by the EMA.[7] Garadacimab was authorized for medical use in the European Union in February 2025.[7][8]
Garadacimab was approved for medical use in the United States in June 2025.[11][13]
Names
Garadacimab is the international nonproprietary name.[14]
