2015年3月25日,美国食品和药品监管局(FDA)昨天批准Anthrasil，炭疽病免疫球蛋白静脉(人)[Anthrax Immune Globulin Intravenous (Human)]，与适宜抗细菌药物联用治疗有吸入性炭疽患者。
吸入性炭疽是一种罕见病可能在暴露于被感染动物或被污的染动物产物后发生，或作为炭疽孢子的有意释放的结果。它是吸入炭疽杆菌[bacterium Bacillus anthracis]的孢子所致。当吸入时，炭疽细菌在机体内复制和产生毒素可造成大规模和不可逆对组织损伤和死亡。为支持国家对可能的炭疽袭击的准备，美国卫生署和人类服务部的物医学高级研究与发展管理局(BARDA)在2011年在BioShield计划下购买Anthrasil作为今天前批准使用将要求从FDA得到紧急使用授权。
Anthrasil是从免疫接种炭疽个体血浆制造。血浆含中和炭疽细菌产生毒素的抗体。
FDA的生物制品评价和研究中心主任Karen Midthun，M.D.说：“今天对批准提供对吸入性炭疽，一种危及生命疾病，批准的其他治疗提供重要的另外治疗。”“这个产品将存储在
美国国家战略储备以便响应一个炭疽紧急时容易得到。”
在动物中研究对Anthrasil的疗效因为在人中不可行或伦理进行适当地对照疗效。兔和猴被暴露至致死量对炭疽孢子雾化吸入剂量，然后用Anthrasil或一种安慰剂治疗，和评价活存。在炭疽-感染的猴用Anthrasil治疗后生存范围从36至70 %与安慰剂组比较生存0%，与在较高剂量Anthrasil有生存增加对趋势。兔感染后用中等剂量Anthrasil治疗表现出26%生存相比较安慰剂组2%生存。在兔中另外研究显示Anthrasil和抗生素联用导致71%生存相比较用单独抗生素治疗动物生存25%生存。
在研究动物中研究对结果提供足够证据Anthrasil合理地有吸入性炭疽人可能获益。美国FDA的动物法则运行从适当和对照良好动物研究支持当它在人中进行是不可行或伦理时FDA批准。
在74例健康志愿者测试产品的安全性。最常观察到副作用是头痛，背痛，恶心和输注部位痛和肿胀。
产品由总部在加拿大Winnipeg的Cangene公司制造。其发展得到HHS准备和响应辅助的BARDA办公室支持。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439752.htm
March 25, 2015 -- The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death.To support the nation’s preparedness against a possible anthrax attack, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) purchased Anthrasil under Project BioShield in 2011 as an experimental drug for the U.S. Strategic National Stockpile. Because Anthrasil was not approved, its use prior to today’s approval would have required an emergency use authorization from the FDA.
Anthrasil is manufactured from the plasma of individuals vaccinated against anthrax. The plasma contains antibodies that neutralize toxins produced by the anthrax bacteria.
“Today’s approval provides an important additional treatment to other FDA-approved therapies for inhalational anthrax, a life-threatening disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “This product will be stored in U.S. Strategic National Stockpile to facilitate its availability in response to an anthrax emergency.”
The efficacy of Anthrasil was studied in animals because it was not feasible or ethical to conduct adequately controlled efficacy studies in humans. Rabbits and monkeys were exposed to a lethal aerosolized dose of B. anthracis spores, then treated with Anthrasil or a placebo, and evaluated for survival. Survival in anthrax-infected monkeys treated with Anthrasil ranged from 36 to 70 percent compared to 0 percent survival in the placebo group with a trend toward increased survival at higher doses of Anthrasil. Rabbits treated with a moderate dose of Anthrasil after infection exhibited 26 percent survival compared to 2 percent survival in the placebo group. Another study in rabbits showed that a combination of Anthrasil and antibiotics resulted in 71 percent survival compared to 25 percent survival in animals treated with antibiotics alone.
The results of studies in research animals provided sufficient evidence that Anthrasil is reasonably likely to benefit humans with inhalational anthrax. The FDA’s Animal Rule 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 humans.
The safety of the product was tested in 74 healthy human volunteers. The most commonly observed side effects were headache, back pain, nausea and infusion site pain and swelling.
The product is manufactured by Cangene Corporation, based in Winnipeg, Canada. It was developed with support from BARDA within HHS’ Office of the Assistant Secretary for Preparedness and Response.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.