奧托薩昔單抗
外觀
單克隆抗體 | |
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種類 | 完整抗體 |
目標 | 炭疽桿菌炭疽 |
臨床資料 | |
商品名 | Anthim、Nyxthracis等 |
其他名稱 | 奧必托昔單抗、奧托昔單抗、ETI-204 |
AHFS/Drugs.com | Monograph |
核准狀況 | |
給藥途徑 | 靜脈注射 |
ATC碼 | |
法律規範狀態 | |
法律規範 |
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識別資訊 | |
CAS號 | 1351337-07-9 |
DrugBank | |
ChemSpider | |
UNII | |
KEGG | |
化學資訊 | |
化學式 | C6444H9994N1734O2022S44 |
摩爾質量 | 145,521.59 g·mol−1 |
奧托薩昔單抗(英語:Obiltoxaximab)是一種單克隆抗體藥物,設計用於治療接觸炭疽芽孢桿菌孢子(炭疽病原),以Anthim等商品名出售。[5][2][6]
該藥物由Elusys Therapeutics公司開發。[2][7]
醫療用途
[編輯]奧托薩昔單抗適用於所有年齡段的患者,與適當的抗菌藥物聯合治療炭疽桿菌引起的吸入性炭疽。[2][3]當替代療法不合適或不可用時,它還適用於所有年齡組的吸入性炭疽暴露後預防。[2][3]
社會和文化
[編輯]法律地位
[編輯]2016年3月,奧托薩昔單抗被美國食品和藥物管理局批准用於治療和預防吸入性炭疽。[8]
2020年9月17日,歐洲藥品管理局的人用藥品委員會通過了積極意見,建議在特殊情況下授予奧托薩昔單抗上市許可,用於治療或暴露後預防吸入性炭疽。[9]該藥品的申請人是SFL製藥德國有限責任公司。[9]它於2020年11月在歐盟獲准用於醫療用途。[3]
參考資料
[編輯]- ^ Summary Basis of Decision (SBD) for Anthim. Health Canada. 23 October 2014 [29 May 2022]. (原始內容存檔於2023-05-28).
- ^ 2.0 2.1 2.2 2.3 2.4 Anthim- obiltoxaximab solution. DailyMed. 9 December 2019 [21 September 2020]. (原始內容存檔於2020-11-30).
- ^ 3.0 3.1 3.2 3.3 Nyxthracis EPAR. European Medicines Agency (EMA). 15 September 2020 [27 November 2020]. (原始內容存檔於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]. (原始內容存檔於2023-03-05).
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Obiltoxaximab (頁面存檔備份,存於網際網路檔案館), 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]. (原始內容存檔於2020-10-19).
- Center for Drug Evaluation and Research: Application Number: 125509Orig1s000: Summary Review (PDF). Food and Drug Administration. [2023-10-04]. (原始內容存檔 (PDF)於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]. (原始內容存檔於2020-09-23). Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
外部連結
[編輯]- Obiltoxaximab. Drug Information Portal. U.S. National Library of Medicine. [2023-10-04]. (原始內容存檔於2022-01-22).
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