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【drug-news】FDA批准第一个治疗先天性因子XIII缺乏
FDA NEWS RELEASE
For Immediate Release: Feb. 17, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves product to prevent bleeding in people with rare genetic defect
Corifact is 1st treatment for congenital Factor XIII Deficiency
The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.
Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.
“This product helps fill an important need,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.
The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.
Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.
Corifact is manufactured by CSL Behring of Marburg, Germany. 免疫学和微生物学器械 (Immunology and Microbiology Devices)...FDA发布批准对该器械上市前批准(PMA)的申请或宣布完成该器械的产品开发协议(PDP) ... (a) 标识.抗菌敏感性测试用培养基是一种预期为了医疗目的、由任何适合支持许多可用...www.pharmnet.com.cn/...?id=155-2005-04-15-快照-临床检验手册 目录文件类型:PDF/Adobe Acrobat- 文字版断与治疗.因此每一位医师,护士及相关人员 都必须熟谙各种检体采取及处理的正确方法.... Fator XIII, Fibrinogen 一单位=125c.c.全血 -152- (2)浓厚红血球: ①外伤或开刀及内出血...www.ntuh.gov.tw/...驗手冊2009.pdf-2011-02-06-药品非临床试验安全性规范文件类型:DOC/Microsoft Word- 文字版此类产品一般应用於医学诊断、治疗或预防,其有效成份包括经基因工程或细胞培养技术制... 2. 选择先天性畸形自然发生率低的品系与品种. 3. 生殖与发育毒性试验第一、二及三期...www2.nsysu.edu.tw/...┦?W?d.doc-1天前-[标签:content2]
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作者:admin@医学,生命科学 2011-02-19 12:41
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