CSL Behring Canada announced today that it has received Notice of Compliance for Berinert (Human C1 Esterase Inhibitor). The company may now market Berinert for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) of moderate and severe intensity. HAE is a rare and serious genetic disorder.
Berinert is the first and only therapy approved for the treatment of hereditary angioedema in Canada. The approval is based on the results of the phase II/III prospective, double-blind, placebo-controlled, randomized, International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), which studied the efficacy of pasteurized Human C1esterase inhibitor (C1-INH) concentrate.
I.M.P.A.C.T. was the world’s largest HAE trial ever.
“The approval of Berinert in Canada marks an important milestone in CSL Behring Canada’s ongoing commitment to addressing the unmet needs of hereditary angioedema patients,” said Dr. Heinz Neuhaus, General Manager of CSL Behring Canada. “CSL Behring is a leader in developing safe, effective and innovative therapies for use in treating patients who have rare and serious disorders. We are pleased to once again expand our rapidly growing portfolio of such products.” The approval of Berinert marks a historic turning point for patients with Hereditary Angioedema and their families, according to Tina Morgan, President, Canadian Immunodeficiencies Patient Organization. “Now that this treatment is available, patients suffering from hereditary angioedema attacks related to C1 Esterase Inhibitor Deficiency have access to a licensed replacement therapy that replaces what their own body fails to produce adequately. This treatment also has a favorable long term side effects profile, which is particularly important for patients suffering from HAE,” said Morgan.