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Cinryze® (C1 Esterase Inhibitor [Human]) Data Presented at 2010 International Scientific Conference of the World Allergy Organization (WAO)
Date:12/6/2010

This World Congress of Allergy Scientific Congress is the first of many such opportunities."

WAO Poster Presentations

In a poster entitled, 'Open-Label Use of Nanofiltered C1 Esterase Inhibitor (Human) (nf-C1 INH) for Treatment or Prophylaxis of Acute Attacks of Hereditary Angioedema (HAE) in Pregnant Subjects,' Dr. Glenn Tillotson Ph.D., FCCP, ViroPharma Incorporated, Exton, PA, presented the experience of 14 pregnant women who were enrolled in pivotal and open label studies of Cinryze.  In this limited sample, Cinryze was utilized for the therapy of acute attacks and as routine prophylaxis of HAE during pregnancy and delivery.  The study included the following data from 10 pregnant subjects enrolled in the open label prophylaxis study who received a median of 34 doses of Cinryze:

  • HAE attack rates for women with pre- and post-pregnancy data improved when using Cinryze for prophylaxis (mean 0.25 attacks per month compared to a pre-Cinryze historical mean monthly attack rate of 4.25 attacks per month; n=8);
  • Seven subjects delivered eight healthy neonates including one set of twins; one subject with a history of miscarriage and ectopic pregnancy had a spontaneous abortion, possibly as a result of an ectopic pregnancy; one subject who received her first exposure to Cinryze after the first trimester/organogenesis delivered a stillborn neonate with multiple congenital anomalies; and one outcome was unknown;
  • The most commonly reported adverse events during therapy in open label trials with pregnant subjects were infection, gastrointestinal disorders, and headache; no serious adverse events were considered related to Cinryze;
  • There was no evidence of clinically relevant anti-C1 INH antibodies;
  • There was no evidence of viral transmission.

In a poster entitled, 'Open-Label Use of Nanofiltered C1 Esterase Inhibitor (Human) (nf-C1 INH for the Proph
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SOURCE ViroPharma Incorporated
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