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——美国FDA批准raxibacumab治疗吸入性炭疽[inhalational anthrax] 2012年12月14日美国食品药品监督管理局(FDA)批准raxibacumab注射液治疗吸入性炭疽，一种通过呼吸细菌炭疽芽孢杆菌[bacterium Bacillus anthracis]的孢子所致的一种传染病形式。Raxibacumab还被批准预防吸入性炭疽当另外治疗不能得到或不适当时。 Raxibacumab是一种单克隆抗体中和炭疽芽孢杆菌产生的毒素，该毒素可致大量和不可逆的组织损伤和死亡。一个单克隆抗体是一种蛋白类似于人抗体，鉴定和中和外来物质像细菌和病毒。炭疽是一种潜在的生物恐怖主义威胁因为孢子对破坏有抗力而且通过释放在空气中容易播散。 FDA批准raxibacumab快车道指定，优先审评，和孤儿产品指定。药物被证实潜在满足紧急医学需求，在没有另外满意治疗存在的领域，分别有提供安全和有效治疗的潜能，和意向治疗一种罕见病。 Raxibacumab是第一个在FDA的动物疗效规则[Animal Efficacy Rule]下被批准的单克隆抗体，这个规则当在人中进行试验不可行或伦理上时允许从适当和对照良好的动物研究的疗效发现支持FDA批准。在这个情中，因为吸入性炭疽是一种罕见和致命性疾病，不可能在人中进行适当疗效试验。 美国FDA药物评价和研究中心抗微生物产品室主任Edward Cox，M.D.，M.P.H说：“炭疽生物恐怖事件发生除了抗菌素 ，将得到 raxibacumab有用治疗，”“尽管抗菌素被批准预防和治疗炭疽感染，raxibacumab是第一个通过中和被细菌炭疽芽孢杆菌产生毒素的被批准药物。” 在一项猴研究和三项兔中研究证实Raxibacumab对吸入性炭疽的有效性。所有动物被给予雾化炭疽芽孢杆菌孢子，而在研究结束时通过存活确定疗效。动物结束不同剂量raxibacumab，安慰剂或通常使用治疗炭疽抗菌素。 与用安慰剂治疗动物比较用raxibacumab治疗动物活存更多。在猴研究中64%动物和在一项兔研究44 %动物接受40 mg/kg的暴露于炭疽生存，与之比较安慰剂组无生存。所有生存动物发生毒素中和抗体。在兔中另外研究显示82 %用抗菌素和raxibacumab治疗暴露于炭疽动物生存与之比较单独接受抗菌素治疗为65 %生存。 在326例健康人志愿者中评价raxibacumab的安全性。常见副作用包括皮疹，肢体痛，瘙痒和睡意。 由Rockville，Md.-基础Human Genome Sciences，与美国美国卫生和人类服务部生物医学高级研究和发展管理局联合发展Raxibacumab。葛兰素史克(GlaxoSmithKline)已经收购Human Genome Sciences 公司。 Food and Drug Administration (FDA) has give approval to Raxibacumab, a drug by GlaxoSmithKline which is expected to treat in inhalational anthrax. Raxibacumab is an injectable medicine which was developed by the Human Genome Sciences. This drug has been granted the orphan status by FDA. Any drug is designated orphan if the disease treated by it is affecting less than 200,000 Americans. Raxibacumab is expected to neutralize the toxins produced by inhalation of spores of a kind of anthrax bacteria. It is the first monoclonal drug to be approved by FDA under its Animal Efficacy Rule. The rule suggests the approval of drugs based on its trials conducted on animals while it feels that testing the drug on humans is not ethical. The drug was approved by the health regulator in Friday against inhalational anthrax caused by Bacillus Anthracis bacteria. Now the drug can be used for the treatment of adults and pediatric patients with the disease. Anthrax is a disease that occurs rarely but is very lethal. It is caused by toxin producing bacteria. "Although antibiotics are approved to prevent and treat anthrax infection, raxibacumab is the first approved agent that acts by neutralizing the toxins produced by B. anthracis", said Edward Cox, MD, the Director of the 0ffice of antimicrobial products at the FDA.
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