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ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema
Date:6/4/2009

re no deaths or serious adverse reactions related to Cinryze administration, or discontinuations due to treatment-emergent adverse events.

"Patients in the United States with HAE have been waiting for a safe and effective emergency treatment for a long time," said Anthony Castaldo, president of the U.S. and International Hereditary Angioedema Association. "Cinryze as a prophylactic treatment has changed the lives of many people living with this debilitating disease; we look forward to a day when this important therapy will be approved in the acute setting."

Patient Labeling for Self Administration

Self-administration of Cinryze provides patients with the ability to administer Cinryze themselves, when properly trained, in the comfort of their own home. This is an important option for some patients because they may no longer need to travel to their doctor's office - sometimes hours away - every three to four days for in-office infusions. Cinryze is administered intravenously though a small needle.

"We are pleased that the FDA has recognized the importance of self-administration for patients," continued Milano. "Empowering patients to administer Cinryze themselves allows them greater flexibility in managing their disease."

About Cinryze(TM) (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 to treat patients with C1 inhibitor deficiency.

Cinryze has been generally well tolerated. 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 tr
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SOURCE ViroPharma Incorporated
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