Ruconest Approved for Acute Angioedema Attacks in HAE
Salix and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).
The FDA approval of Ruconest was based on a randomized, double-blind, placebo-controlled, Phase 3 trial (RCT) which included an open-label extension (OLE) phase and is supported by the results of two additional RCTs and two additional OLE studies.
A statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population (n=75) between Ruconest and placebo (P=0.031); the median time to beginning of symptom relief was 90 minutes for Ruconest patients (n=44) and 152 minutes for placebo patients (n=31).
Ruconest 50 IU/kg will be available later this year in 2014.