Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023. Based on the trial results, CSL will file global regulatory submissions later in 2023. A humanized anti-factor XIIa monoclonal antibody, garadacimab is self-administered by subcutaneous administration once monthly, which is a huge convenience for patients, Andrew Nash, CSL’s chief scientific officer and senior vice president for research, told BioWorld.