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ViroPharma Announces Publication of Cinryze™ (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
Date:8/5/2010

completed, 88 subjects chose to enroll in an open-label extension study for the treatment of acute attacks. At a median of 11 months, 82 of the enrolled subjects had received open-label C1-inhibitor treatment for a total of 447 separate attacks, with the number of attacks per subject ranging from one to 57 (median 3). The median time to a response for the 447 attacks was 30 minutes, irrespective of whether a subject was given open-label treatment fewer than four times, four to nine times, or 10 times or more. The Kaplan–Meier estimate of the proportion of attacks that responded to treatment within four hours was 93 percent.

About Cinryze™ (C1 esterase inhibitor [human])

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe in patients with C1 inhibitor deficiency.

The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials. Severe hypersensitivity reactions may occur. Thrombotic events have occurred in patients receiving high dose off-label C1 inhibitor therapy well above the approved treatment dosage regimen. 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 patients 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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SOURCE ViroPharma Incorporated
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