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Garadacimab
Medication From Wikipedia, the free encyclopedia
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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]
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Medical uses
Garadacimab is indicated for routine prevention of recurrent attacks of hereditary angioedema in people aged twelve years of age and older.[6][7]
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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.[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
Garadacimab is the international nonproprietary name.[13]
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References
External links
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