Accovion supports CSL Behring in successfully obtaining marketing authorization for Berinert®
Berinert®, a human C1 esterase inhibitor (C1-INH) for treating acute episodes of facial or abdominal hereditary angioedema (HAE) in adults and adolescents has obtained approval from the US Food and Drug Administration (FDA). HAE is a rare and serious autosomal dominant genetic disease caused by C1-INH deficiency. Symptoms include sudden onset of edema (swelling) of the face, abdomen, extremities, or the larynx (which can be life threatening). Berinert® is a unique new treatment option for HAE, being the first C1-INH to be licensed in the USA for treatment of acute attacks of HAE.
Approval was based on the results of the I.M.P.A.C.T. (International Multi-center Prospective Angioedema C1-Inhibitor Trial) study, a double-blind, placebo-controlled, phase II/III study of 124 patients with HAE and acute episodes of moderate to severe facial or abdominal angioedema. This study successfully demonstrated the efficacy and safety of Berinert®. In addition, efficacy and safety data have been collected from over 400,000 treatments in Germany, Austria, Switzerland, and several other countries, where the drug is marketed with the trade name Berinert® P.