The FDA has approved Berinert (C1 Esterase Inhibitor [human], from CSL Behring), a plasma-derived concentrate of C1 Esterase Inhibitor, for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adults and adolescents. The approval was based on results from the Phase 2/3 prospective, double-blind, placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (IMPACT), which studied the efficacy and safety of C1-inhibitor (C1-INH) concentrate in 124 HAE patients with acute, moderate, or severe abdominal or facial attacks. Main study endpoints were time to onset of symptom relief from HAE attacks, proportion of subjects with worsening clinical HAE symptoms, and safety. The study found that C1-INH is effective and safe in rapidly treating acute abdominal and facial skin swellings in adults and adolescents with HAE. The median time to symptom relief was 30 minutes after receiving C1-INH compared with 1.5 hours with a placebo.
Berinert will be available in single-use vials containing 500units of lyophilized concentrate.
For more information call (800) 504-5434 or visit www.berinert.com.