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Angioneurotic Edema
CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema
March 21st, 2008
CSL Behring has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval to market its C1-esterase inhibitor concentrate in the United States 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, that studied the efficacy of pasteurized C1-INH concentrate. The proposed indication is for the treatment of acute attacks in patients with HAE. Currently, there are no...
Source: Health Business Week (2008-03-21)
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