The Food and Drug Administration (FDA) has approved Haegarda (C1 esterase inhibitor [human]; CSL Behring) subcutaneous (SC) injection for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescents and adults. It is not indicated to treat acute HAE attacks.
Haegarda is the first C1 esterase inhibitor (human) SC injection approved for this indication. The human plasma-derived, purified, pasteurized, lyophilized concentrate is derived from large pools of human plasma from U.S. donors. The SC formulation allows for self-injection at home by the patient or the caregiver after receiving proper training. Haegarda works by replacing deficient or dysfunctional natural C1-INH, restoring functional levels above >40% of normal levels.
The approval was supported by efficacy data from a multi-center controlled trial (n=90) in patients aged 12–72 years with symptomatic HAE. Study patients were randomized to receive SC 40 IU/kg or 60 IU/kg twice weekly, and the effect was compared to placebo over 16 weeks. During the treatment period, study patients in both groups exhibited significantly fewer HAE attacks vs. placebo.
The most frequently reported side effects included injection site reactions, hypersensitivity reactions, nasopharyngitis, and dizziness.
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