Cinryze sBLA for hereditary angioedema acute attacks
Executive Summary
ViroPharma, whose Cinryze recently became the first drug approved in the U.S. for hereditary angioedema, submits an sBLA for approval of the drug in the acute attack setting. FDA approved Cinryze, a C1 esterase inhibitor, as an orphan drug for HAE prophylaxis Oct. 10, at which time ViroPharma withdrew the portion of its BLA pertaining to acute attacks (1"The Pink Sheet," Nov. 3, 2008, p. 17). The sBLA filed on Dec. 1 is based on reanalysis and resubmission of data from a pivotal Phase III trial of Cinryze, along with interim data from ongoing open-label usage in the acute setting, ViroPharma says. Cinryze is competing with CSL Behring's C1 inhibitor, Berinert, to be first with the orphan indication in HAE acute attacks. FDA's PDUFA date for the Berinert application was Dec. 5
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