CSL Behring Submits NDS Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema

TORONTO, April 17 /CNW/ -- CSL Behring has filed a new drug submission (NDS) with Health Canada seeking approval to market its C1-esterase inhibitor concentrate in Canada for the treatment of hereditary angioedema (HAE), a rare and serious genetic disorder. The submission is based on the recently completed phase II/III prospective, double-blind placebo-controlled International Multi-center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest HAE trial ever conducted, that studied the efficacy of pasteurized C1-INH concentrate.

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