2016年3月22日，美国食品与药品管理局（FDA）近日批准了一款新的吸入性炭疽治疗药物Anthim（obiltoxaximab），这是一种单克隆抗体，旨在中和炭疽杆菌（anthrax）产生的毒素。Anthim由Elusys Therapeutics公司开发，通过FDA的动物法则（Animal Rule）获批用于吸入性炭疽的治疗及预防性治疗。FDA的动物法则允许在人类中开展充分控制疗效研究不可行或不道德的情况下，采用来自充分的良好对照的动物研究数据来支持批准产品上市。
Anthim的获批，是基于动物试验的疗效数据及人体安全性研究数据。动物试验表明，与安慰剂组相比，Anthim注射治疗的动物组有更高比例的动物存活，Anthim联合其他抗菌药物可提高生存结局。另外，该药物也在320名健康志愿者中进行了安全性评估，研究中最常报道的副作用包括头痛、瘙痒、上呼吸道感染、咳嗽、鼻塞、荨麻疹，以及注射部位出现青紫、肿胀和疼痛。
Anthim药物标签中附带有一个黑框警告，警告医疗服务提供者及患者，该药可能引起过敏反应，包括过敏性休克。因此患者在治疗时需要监测和治疗过敏性反应。
然而，FDA表示，鉴于炭疽热是一种非常严重和致病的疾病，采用Anthim治疗的效应预计将大于风险。
吸入性炭疽是一种罕见的疾病，由吸入炭疽杆菌的孢子所致，可通过空气释放扩散，当人体接触到受感染的动物、或受污染的动物产品或人为蓄意释放（生化袭击）的炭疽孢子后便可能感染；吸入孢子后，炭疽杆菌会在体内增殖并产生毒素，引发严重的不可逆的组织损伤和死亡。
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. |
