Summary

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• This summary is based on the review of two randomized controlled trials. ^[1-2]
• Andembry (garadacimab-gxii) is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
• In patients with HAE aged ≥12 years, the mean HAE attack rate decreased by 95% from the run-in period; 60% of patients were attack-free, and 93% rated their response to garadacimab as “good” or “excellent”.
• In patients with type I or type II HAE aged ≥12 years, the mean number of investigator-confirmed HAE attacks per month was 0.27 (95% confidence interval [CI] 0.05 to 0.49) in the garadacimab group versus 2.01 (95% CI 1.44 to 2.57; p<0.0001) in the placebo group, representing an 87% reduction; the median number of monthly attacks was 0 (interquartile range [IQR] 0.00–0.31) with garadacimab and 1.35 (IQR 1.00–3.20) with placebo.
• Among 159 patients with HAE aged ≥12 years, 133 experienced at least one treatment-emergent adverse event (TEAE), with a rate of 0.23 events per administration and 2.84 events per patient-year; 13% experienced garadacimab-related TEAEs, primarily injection-site reactions, leading to one treatment discontinuation due to a moderate injection-site reactions (ISRs). No abnormal bleeding, thromboembolic, severe hypersensitivity, or anaphylactic events were observed. Common TEAEs included upper-respiratory tract infections, nasopharyngitis, and headaches, with no increased risk of bleeding or thromboembolic events associated with factor XIIa (FXIIa) inhibition.
• There is no population types or subgroups information available in the reviewed studies.