Fast, Effective & Sustained Protection1,3,6
As demonstrated in the VANGUARD Pivotal Phase 3 Study
ANDEMBRY significantly reduced HAE attacks
* The primary endpoint of the number of HAE attacks per month was summarized descriptively for the 6 months of the Active Arm and the 6-month Placebo Arm period by median and mean.
As demonstrated in the VANGUARD Pivotal Phase 3 Study
ANDEMBRY Demonstrated a Significant Reduction in HAE Attacks Requiring Rescue Medication and Number of Moderate or Severe HAE Attacks
* The secondary endpoints of the number of HAE attacks requiring rescue medication and the number of moderate or severe HAE attacks were summarized descriptively for the 6 months of the Active Arm and the 6-month Placebo Arm period by median and mean.
As demonstrated in the VANGUARD Pivotal Phase 3 study and OLE Subgroup Analysis
ANDEMBRY has a fast onset of protection, substantially reduces HAE attacks from Week 1, and provides sustained protection for up to 2 years — and counting1,3,4
*N=64 (39 ANDEMBRY, 25 placebo), both administered once monthly.
† Data presented are from an interim analysis of the VANGUARD open-label study which evaluated the long-term safety and efficacy of ANDEMBRY (200 mg/month) in 161 patients with HAE (57 rollover patients from the pivotal phase 3 trial [36 treated with ANDEMBRY, 21 placebo]). Regardless of prior treatment arm, rollover patients received ANDEMBRY 200 mg SC once monthly in the OLE. Minimum treatment period was 12 months. Data cutoff: February 2023. At the time of the data cut, not all patients reached 22-24 months of therapy. Of the 21 placebo patients who rolled over to ANDEMBRY at Month 6, 3 reached Months 22-24 of therapy with ANDEMBRY. Of the 36 ANDEMBRY patients who rolled over at Month 6, 7 reached Months 22-24 of therapy with ANDEMBRY.4,6
References: 1. 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. 2. Data on File. Available from CSL Behring as DOF AND-001. 3. Staubach P, Tachdjian R, Li HH, et al. Timing of onset of garadacimab for preventing hereditary angioedema attacks. Clin Exp Allergy. 2024;doi:10.1111/cea.14568. 4. Magerl M, Reshef A, Farkas H, et al. Long-term efficacy and safety of subcutaneous garadacimab for prophylaxis of hereditary angioedema attacks: Results from a multicentre phase 3 study and open-label extension. Poster presented at: the European Academy of Allergy and Clinical Immunology Annual Congress; June 9-11, 2023: Hamburg, Germany. 5. Tachdjian R, Li HH, Hsu C, et al. Early onset of protection against hereditary angioedema attacks from Week 1 with garadacimab in pivotal Phase 3 (VANGUARD) study. Poster presented at: American College of Allergy Asthma & Immunology Annual Scientific Meeting; November 9-13, 2023: Anaheim, CA. 6. Reshef A, Hsu C, Katelaris CH, et al. Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: phase 3 open-label extension study. Allergy. 2024;doi:10.1111/all.16351.