2016年3月18日美国食品和药品监管局(FDA)批准Anthim (obiltoxaximab)注射剂与适当抗细菌药联用治疗吸入性炭疽病。Anthim还被批准预防吸入性炭疽病当当另外治疗不能得到或不适当时。
吸入性炭疽病是一种罕见病，暴露于被感染动物或被动物产品污染后可能发生，或作为炭疽病孢子有意释放的结果。它是吸入细菌炭疽杆菌的孢子所致。当吸入时，炭疽病细菌在机体内复制和产生毒素可致大规模的和不可逆组织损伤和死亡。炭疽病是一种潜在的生物恐怖主义威胁因为孢子是抗破坏和通过在空气中释放播散。
FDA的药品评价和研究中心中抗微生物产品室主任Edward Cox，M.D.，M.P.H说：“因为准备是应对任何生物恐怖主义的基石，我们很高兴看到继续努力开发对炭疽病治疗”。
Anthim是一个单克隆抗体中和炭疽杆菌产生的毒素。Anthim是在FDA的动物法规条例下被批准，条例允许来自适当和控制良好动物研究支持FDA批准当在人中进行疗效试验是不可行或不伦理时。
Anthim对治疗和预防吸入性炭疽病的有效性是在动物中进行研究中被证实根据研究结束时生存。用治疗的动物比用安慰剂治疗动物生存更多动物。Anthim与抗细菌药联用比单独抗细菌治疗导致更高生存结局。
在320例健康志愿者中评价Anthim的安全性。报道的最频繁副作用是头痛，瘙痒。上呼吸道感染，咳嗽，鼻塞，荨麻疹，和瘀伤，肿胀和输注部位疼痛。
Anthim带有一个黑框警告警戒患者和卫生保健提供者药物可能致过敏反应(超敏性)，包括一种严重反应被称为过敏性休克。应在患者可被监视和对过敏性休克治疗条件下给予Anthim。但是，鉴于炭疽病是一种非常严重和往往是致命的条件， Anthim为治疗炭疽病的获益期望胜过这个风险。
Anthim是由新泽西Pine Brook Elusys Therapeutics，Inc. 与美国卫生和人类服务部的生物医学高级研究和发展管理局结合开发。
Anthim, obiltoxaximab (ETI-204)
Anthim Approval History
FDA approved: Yes (First approved March 18th, 2016)
Brand name: Anthim
Generic name: obiltoxaximab
Company: Elusys Therapeutics, Inc.
Treatment for: Anthrax Prophylaxis, Anthrax
Anthim (obiltoxaximab) is a monoclonal antibody (mAb) anthrax antitoxin for the treatment and prevention of inhalational anthrax due to Bacillus anthracis
IMPORTANT SAFETY INFORMATION
WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion.  ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
WARNINGS AND PRECAUTIONS
Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Premedication with diphenhydramine is recommended prior to administration of ANTHIM.  Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
ADVERSE REACTIONS
The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax.  The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.
USE IN SPECIFIC POPULATIONS
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population.