As demonstrated in the VANGUARD Pivotal Phase 3 study
Adverse events with ANDEMBRY
were similar to placebo
* Consists of nasopharyngitis, rhinitis, and upper respiratory infections.
† Consists of abdominal pain and abdominal pain lower.
ANDEMBRY demonstrated favorable long-term safety (primary endpoint) in the OLE1
Data cut-off: Feb 13, 2023.
‡ Two patients with HAE-nC1-INH were not included in the primary safety analysis.
§ TEAEs are categorized as ISR based on medical review of relevant Preferred Terms.
¶ In the VANGUARD pivotal phase 3 trial.
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AE, adverse event; ISR, injection-site reaction; OLE, open-label extension; TEAE, treatment-emergent adverse event.
References: 1. Anderson J, Levy DS, Sussman GL, et al. Long-term safety and efficacy with garadacimab for hereditary angioedema prophylaxis in an open-label extension study. Presented at: American College of Allergy, Asthma, and Immunology Annual Meeting; November 9-13, 2023; Anaheim, CA. 2. Craig TJ, Reshef A, Li HH, et al. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2023 Apr 15;401(10384):1266]. Lancet. 2023;401(10382): 1079-1090. doi:10.1016/S0140-6736(23)00350-1.