【medical-news】FDA advisory committee recommends approval
The Blood Products Advisory Committee to the FDA has voted unanimously that there is sufficient evidence of the safety and efficacy for the approval of Lev's C1 inhibitor Cinryze(TM)) for the prophylactic treatment of hereditary angioedema (HAE). If approved, it would be the first C1 inhibitor replacement therapy for patients with HAE in the U.S. The FDA issued a complete response letter in January, in which it requested information with respect to chemistry, manufacturing and controls, as well as additional analyses of existing efficacy data from the Cinryze(TM) trials. No additional safety information and no additional clinical trials were requested in the FDA's letter. Lev subsequently filed its complete response to the FDA. The FDA will review the advisory committee's recommendations in connection with its consideration of Lev's BLA
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作者:admin@医学,生命科学 2010-12-02 17:11
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