FDA批准用于吸入性炭疽治疗的唯一药物：瑞希巴库

FDA批准用于吸入性炭疽治疗的唯一药物：瑞希巴库

来源：大众医药网

据报道，美国食品药品管理局(FDA)于2012年12月14日宣布批准注射用瑞希巴库(raxibacumab)用于吸入性炭疽治疗，该药物同时还被批准在没有或不适合替代药物治疗的情况下作为吸入性炭疽的预防用药。瑞希巴库是一种单克隆抗体，能够中和炭疽芽胞杆菌产生的毒素，后者可导致广泛且不可逆性组织损伤和死亡。

　　炭疽是一种潜在的生物恐怖威胁，因为其芽孢难以杀灭且易于通过空气传播。

　　瑞希巴库是首个基于FDA动物有效性规则被批准的单克隆抗体。该规则是在人体试验不可行或不符合伦理的情况下，只基于来自控制良好的充分动物研究的有效性结果的数据支持，FDA可以批准其用于临床使用。瑞希巴库实验研究证明，在1项猴子和3项家兔实验中证实了治疗吸入性炭疽的有效性。对所有实验动物给予炭疽杆菌芽孢气雾剂，在研究结束时通过存活率确定有效性。动物接受不同剂量的瑞希巴库、安慰剂或通常用于炭疽治疗的抗生素。

　　与接受安慰剂治疗的动物相比，接受瑞希巴库治疗动物存活比例更高。在猴子研究和1项家兔研究中，暴露于炭疽的动物接受40mg/Kg剂量的瑞希巴库，存活率分别为64%和44%，而安慰剂组无一存活，所有存活动物体内均产生了中和毒素的抗体。另1项家兔研究显示，接受抗生素和瑞希巴库治疗的动物存活率为82%，而单纯接受抗生素治疗的动物存活率仅为65%。

　　瑞希巴库的安全性人体试验在326例健康志愿者中得到了评价，常见不良反应包括皮疹、剧痛、瘙痒和困倦。

　　On December 14, 2012, the US Food and Drug Administration (FDA) announced the approval of injectable raxibacumab for the treatment of inhalational anthrax. The drug is also approved for the prevention of inhalational anthrax when alternative therapies are not available or not appropriate. Raxibacumab is a monoclonal antibody that neutralizes toxins produced by Bacillus anthracis that can cause massive and irreversible tissue injury and death.

　　Anthrax is a potential biological terrorism threat because the spores are resistant to destruction and can be easily spread by release in the air.Raxibacumab is the first monoclonal antibody approved under the FDA's Animal Efficacy Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct trials in human beings. Raxibacumab's effectiveness for the treatment of inhalational anthrax was demonstrated in 1 study in monkeys and 3 studies in rabbits. All animals were administered aerosolized B anthracis spores, and efficacy was determined by survival at the end of the studies. Animals received varying doses of raxibacumab, placebo, or antibiotics normally used to treat anthrax.

　　More animals treated with raxibacumab survived compared with animals treated with placebo. Sixty-four percent of animals in the monkey study and 44% of animals in 1 rabbit study that received the 40 mg/Kg dose of raxibacumab survived exposure to anthrax, compared with none in the placebo groups. All surviving animals developed toxin-neutralizing antibodies. Another study in rabbits showed that 82% of animals treated with antibiotics and raxibacumab survived exposure to anthrax compared with 65% of animals receiving antibiotic treatment alone.

　　The safety of raxibacumab was evaluated in 326 healthy human volunteers. Common adverse effects included rash, extremity pain, itching, and drowsiness.

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