CSL Behring has been granted national marketing authorization in Italy and Luxembourg to market Berinert for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings to 28 the number of countries (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.
In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal and facial attacks of HAE, a rare and serious genetic disorder, in adolescent and adult patients. CSL Behring completed the European Mutual Recognition Procedure (MRP) for Berinert in 23 countries in December, 2008. Marketing authorization was also granted for Australia in January, 2010, and applications for licensing in Canada and Israel have also been filed with authorities. Berinert has been marketed in Germany for more than 30 years.
The approvals are mainly based on the results of the phase-II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (IMPACT), the largest single placebo-controlled HAE trial ever, that studied the efficacy of pasteurized C1-esterase inhibitor (C1-INH) concentrate.
“It is very good news that this well-established therapy, which has helped so many patients to live without the fear of life-threatening and debilitating HAE attacks, is now available to even more HAE patients in Europe,” said Dr Marco Cicardi, professor of Internal Medicine at the University of Milan, Italy. “CSL Behring is to be commended for its dedication to this relatively small patient community for whom treatment options have been limited for so long.”
HAE is a genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, feet, the face, the abdomen, and/or the larynx. Patients who have abdominal attacks of HAE can experience episodes of severe pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face and larynx can result in airway closure, asphyxiation, and, if untreated, death. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.
The effective date of the marketing authorization in Italy and Luxembourg was March 29, 2010.
Berinert, a plasma-derived intravenous therapy, treats the fundamental cause of hereditary angioedema (HAE) symptoms by providing C1-INH deficient patients with the missing human protein.
CSL Behring is a global leader in the plasma protein biotherapeutics industry.