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Approved in the EU in December 2023, it offers a novel upstream mechanism of action with convenient once-monthly subcutaneous dosing. In pivotal trials, it demonstrated an 87% reduction in HAE attacks versus placebo. It is listed in the NICE BNF as a specialist drug for HAE management.","brandName":"Filsuvez","companyId":"csl-behring","ecosystem":[],"mechanism":{"target":"Activated Factor XII (FXIIa)","novelty":"First-in-class anti-FXIIa antibody for HAE prophylaxis","modality":"Monoclonal antibody","drugClass":"Anti-Factor XIIa monoclonal antibody","explanation":"Garadacimab is a fully human monoclonal antibody targeting activated coagulation Factor XII (FXIIa). In hereditary angioedema (HAE), uncontrolled activation of the contact activation system leads to excessive bradykinin production, causing recurrent episodes of severe tissue swelling. By inhibiting FXIIa at the top of the cascade, garadacimab blocks kallikrein activation and subsequent bradykinin generation, preventing HAE attacks. It represents a novel upstream approach compared to existing therapies that target downstream mediators.","oneSentence":"Monoclonal antibody that inhibits activated Factor XII (FXIIa), preventing the generation of bradykinin which causes angioedema attacks.","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"CSL Behring","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"garadacimab","indications":{"approved":[{"name":"Epidermolysis bullosa","diseaseId":"epidermolysis-bullosa","approvalDate":"","lineOfTherapy":"","approvalCountry":"United 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