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news.CSL Behring has filed a new drug submission with Health Canada seeking approval to market its C1-esterase inhibitor concentrate in Canada for the treatment of hereditary angioedema, a rare and serious genetic disorder.
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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.”