Approximately 88 subjects with documented hereditary angioedema (HAE) were screened and enrolled in an acute treatment open-label protocol. Subjects were eligible to receive open-label injections of Cinryze for acute attacks of angioedema occurring at any anatomical site. Subjects could receive a second open-label injection of Cinryze 60 minutes later if they had not improved. Approximately 24 subjects have been followed for greater than one year.
Approximately 447 acute attacks were treated in 82 subjects who had at least one attack. According to additional study findings, the median time to improvement was 30 minutes in the 447 attacks that occurred, and 93.4% of patients reported improvement in symptoms within four hours, regardless of how many times they had previously received Cinryze.
None of the subjects in this study treated for laryngeal attacks required hospitalization or intubation, and no serious adverse reactions were considered related to Cinryze administration, the company said.
Bruce Zuraw, professor of medicine, University of San Diego, said: “The open label extension study findings indicated Cinryze was well tolerated in this study, and successfully treated all of the types of acute HAE attacks seen during the trial. These results recognize the potential for Cinryze to treat acute attacks of HAE.”