Monoclonal antibody | |
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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 |
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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, 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]
Garadacimab is indicated for routine prevention of recurrent attacks of hereditary angioedema in people aged twelve years of age and older. [6] [7]
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]
Garadacimab is the international nonproprietary name. [13]