奥托萨昔单抗
| 单克隆抗体 | |
|---|---|
| 种类 | 完整抗体 |
| 目標 | 炭疽杆菌炭疽 |
| 臨床資料 | |
| 商品名 | Anthim、Nyxthracis等 |
| 其他名稱 | 奥必托昔单抗、奥托昔单抗、ETI-204 |
| AHFS/Drugs.com | Monograph |
| 核准狀況 | |
| 给药途径 | 静脉注射 |
| ATC碼 | |
| 法律規範狀態 | |
| 法律規範 |
|
| 识别信息 | |
| CAS号 | 1351337-07-9 |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| 化学信息 | |
| 化学式 | C6444H9994N1734O2022S44 |
| 摩尔质量 | 145,521.59 g·mol−1 |
奥托萨昔单抗（英语：Obiltoxaximab）是一种单克隆抗体药物，设计用于治疗接触炭疽芽孢杆菌孢子（炭疽病原），以Anthim等商品名出售。[5][2][6]
该药物由Elusys Therapeutics公司开发。[2][7]
医疗用途
奥托萨昔单抗适用于所有年龄段的患者，与适当的抗菌药物联合治疗炭疽杆菌引起的吸入性炭疽。[2][3]当替代疗法不合适或不可用时，它还适用于所有年龄组的吸入性炭疽暴露后预防。[2][3]
社会和文化
法律地位
2016年3月，奥托萨昔单抗被美国食品和药物管理局批准用于治疗和预防吸入性炭疽。[8]
2020年9月17日，欧洲药品管理局的人用药品委员会通过了积极意见，建议在特殊情况下授予奥托萨昔单抗上市许可，用于治疗或暴露后预防吸入性炭疽。[9]该药品的申请人是SFL制药德国有限责任公司。[9]它于2020年11月在欧盟获准用于医疗用途。[3]
参考资料
- ^ Summary Basis of Decision (SBD) for Anthim. Health Canada. 23 October 2014 [29 May 2022]. （原始内容存档于2023-05-28）.
- ^ 2.0 2.1 2.2 2.3 2.4 Anthim- obiltoxaximab solution. DailyMed. 9 December 2019 [21 September 2020]. （原始内容存档于2020-11-30）.
- ^ 3.0 3.1 3.2 3.3 Nyxthracis EPAR. European Medicines Agency (EMA). 15 September 2020 [27 November 2020]. （原始内容存档于2023-09-23）. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ Nyxthracis Product information. Union Register of medicinal products. [3 March 2023]. （原始内容存档于2023-03-05）.
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Obiltoxaximab （页面存档备份，存于互联网档案馆）, American Medical Association.
- ^ Hou AW, Morrill AM. Obiltoxaximab: Adding to the Treatment Arsenal for Bacillus anthracis Infection. The Annals of Pharmacotherapy. October 2017, 51 (10): 908–913. PMID 28573869. S2CID 39810240. doi:10.1177/1060028017713029.
- ^ Anthim (obiltoxaximab) Injection. U.S. Food and Drug Administration (FDA). 26 April 2016 [18 October 2020]. （原始内容存档于2020-10-19）.
- Center for Drug Evaluation and Research: Application Number: 125509Orig1s000: Summary Review (PDF). Food and Drug Administration. [2023-10-04]. （原始内容存档 (PDF)于2022-04-06）.
- ^ Greig SL. Obiltoxaximab: First Global Approval. Drugs. May 2016, 76 (7): 823–30. PMID 27085536. S2CID 46099559. doi:10.1007/s40265-016-0577-0.
- ^ 9.0 9.1 Obiltoxaximab SFL: Pending EC decision. European Medicines Agency (EMA). 17 September 2020 [21 September 2020]. （原始内容存档于2020-09-23）. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
外部链接
- Obiltoxaximab. Drug Information Portal. U.S. National Library of Medicine. [2023-10-04]. （原始内容存档于2022-01-22）.
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