The submission is based on the recently completed Phase II/III prospective, double-blind placebo-controlled international multi-center prospective angioedema C1-inhibitor trial, which studied the efficacy of pasteurized C1-INH concentrate.
Val Romberg, senior vice president of R&D at CSL Behring, said: “We are confident that our expertise in developing and manufacturing plasma-derived protein therapies will be advantageous in our pursuit of approval in Canada.”