Phase III results for CSL 312 meet primary and secondary objectives in hereditary angioedema
CSL Behring announced positive top-line Phase III results for CSL 312 (garadacimab), the company's investigational first-in-class monoclonal antibody inhibiting Factor XIIa being developed as a long-term preventive treatment for patients with hereditary angioedema (HAE)
The study met its primary and secondary efficacy objectives and also demonstrated favorable safety and tolerability. CSL aims to begin filing with global health authorities at the end of the current fiscal year for full approval.
The multicenter, double-blind, randomized, placebo-controlled, parallel-arm study (also known as VANGUARD) evaluated the efficacy and safety of monthly subcutaneous garadacimab administration in the prevention of HAE attacks compared to the placebo for six months. Full results from the study will be presented at an upcoming scientific congress and published in a peer-reviewed journal.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.