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ViroPharma Announces Positive CHMP Opinion for Cinryze® (C1 Inhibitor [Human]) in European Union
Date:3/18/2011

as designated an orphan medicinal product on October 8, 2009. Upon granting of a Centralized Marketing Authorization and retention of the orphan medicinal product designation, Cinryze would be entitled to a period of 10 years market exclusivity in respect of the approved therapeutic indication. This 10-year market exclusivity period could be extended cumulatively to 12 years when the results of all studies conducted in compliance with an agreed pediatric investigation plan are completed and included in the summary of product characteristics.

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 was approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.  In the E.U., the recommended indication is for 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.

Severe hypersensitivity reactions to Cinryze may occur.  Thrombotic events have occurred in patients receiving Cinryze for routine prophylaxis, 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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SOURCE ViroPharma Incorporated
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