Product information and disease descriptionPlace of product in therapyApproaches to treatment
Place in treatment, anticipated use, and care setting
1 evidence topic · 6 sources
Summary
The trial supporting the accepted BLA permitted enrollment of adults and adolescents aged 16 years or older with type 1 or type 2 HAE. The investigational regimen is a single 50-mg intravenous infusion, with outpatient administration anticipated. HAELO required discontinuation of long-term prophylaxis before dosing, so its placebo-controlled findings should not be interpreted as an active-comparator trial or as evidence for routine combination with ongoing prophylaxis. The investigational regimen does not replace the guideline requirement for rapid access to on-demand treatment.