CSL Behring announced today it has been granted national marketing authorization in Israel to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. With this most recent approval, Berinert is now licensed in 30 countries, including Europe, Japan, North America, South America and Australia.
CSL Behring completed a European Mutual Recognition Procedure (MRP) for Berinert for the treatment of acute attacks of HAE, a rare and serious genetic disorder, in 23 European countries in December 2008. It was subsequently granted all respective national licenses. In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients in the United States. National marketing authorizations were also granted for Berinert in Australia in January 2010 and Canada in June 2010. CSL Behring has marketed its C1-esterase inhibitor concentrate in Germany for more than 30 years. CSL Behring also markets it in Argentina, Japan and Switzerland.
The approvals for Berinert are mainly based on the results of the phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.1), the largest single placebo-controlled HAE trial ever, that studied the efficacy of a C1-esterase inhibitor (C1-INH) concentrate.
"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," said Dr. Avner Reshef, Head of the Allergy & Immunology Unit of Sheba Medical Center, Israel. "Because it is rare, and symptoms can appear similar to other medical conditions, HAE is often misdiagnosed. Swellings are wrongly treated as allergic reactions and abdominal pain can often lead to unnecessary surgery."
"For years, most HAE patients in Israel had to rely on therapy with drugs that are associated with severe side-effects or which were not effective enough in treating symptoms. Other patients had no therapy at all and were forced to endure often very painful or disfiguring attacks," explained Tali Levy, head of the national patient association EDEMA. "However, a patient's biggest fear is usually the prospect of having an attack of the larynx or throat, which can be life-threatening. Only the assurance that an effective treatment such as Berinert is immediately available can remove this fear and allow such people to live a normal life."
Understanding the role of genetic variants in male infertility