According to the company, the Berinert marketing approval is given on the basis of positive results from Phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.1).
CSL Behring already has Berinert marketing rights in the US, Australia, Canada, Germany, Argentina, Japan and Switzerland.
Sheba Medical Center, Israel Allergy & Immunology Unit head Avner Reshef said the approval of Berinert in Israel is a very important step toward optimal treatment of patients with HAE, many of whom have suffered with the symptoms of this debilitating disease for years.