Subgroup Analyses Of Pivotal And Open Label Prevention Trials Showed Effectiveness Of ViroPharma's Cinryze® (C1 Esterase Inhibitor [Human]) In Prevention Of Angioedema Attacks In Patients With Hereditary Angioedema (HAE) Poorly Controlled On Anabolic Androgens
Lead author Bruce L. Zuraw, Professor of Medicine, Chief of the Section of Allergy and Immunology, and Director of the Allergy and Immunology Training Program at the University of California School of Medicine, San Diego delivered these findings during an oral platform presentation at the 8 th C1 Inhibitor Deficiency Workshop in Budapest, Hungary.
"While clinical trials have demonstrated the efficacy and safety of Cinryze for the long-term prevention of HAE, these data demonstrate that Cinryze is an important option, even in patients who have been managed on anabolic androgens and continue to experience multiple attacks of HAE," said Dr. Zuraw. "It reinforces current evidence based guidelines for the management of HAE, especially given the long-term risk/benefit of anabolic androgens."
The abstract 'Anabolic androgen experience and response to CINRYZE (C1 esterase inhibitor [human]) in the prevention trials in patients with HAE' will be published in the May edition of The Journal of Angioedema.
About Cinryze ® (C1 esterase inhibitor [human]) Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment. Cinryze is for intravenous use only.Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. Monitor patients with known risk factors for thrombotic events. With any blood or plasma derived product, there may be a risk of transmission of infectious agents, e.g. viruses and, theoretically, the CJD agent. The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.
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