Does the Committee agree with FDAs proposal to maintain the current criteria?
(The current criteria are: Radiolabeling studies should be performed in at least two separate centers (laboratories) with a total of 20-24 healthy donors. The mean recovery at 24 hours for each unit should be > 75% with SD < 9%; and the one sided 95% lower confidence limit for the population proportion of successes > 70% .) The Committee agreed with FDAs proposal to maintain the current criteria (15 yes votes, 2 no votes). Question 2 was not posed to the Committee since it voted affirmatively to question 1. Topic II: Lev Pharmaceuticals, Inc. Clinical Trial for the Use of Human Plasma-Derived C1 Esterase Inhibitor (Cinryze) for the Prophylaxis of Hereditary Angioedema Attacks FDA sought the advice of the Committee on whether the safety and efficacy evidence is sufficient for approval of CinryzeTM for prophylactic treatment of hereditary angioedema (HAE). Dr. Felice DAgnillo introduced the topic to the Committee and provided an overview of C1 esterase inhibitor, the epidemiology and cur
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