Pappas Georgios, Ierodiakonou Vrettos, Falagas Matthew E
Institute of Continuing Medical Education of Ioannina, 45333, loannina, Greece.
Clin Ther. 2009 Jul;31(7):1595-603. doi: 10.1016/j.clinthera.2009.06.016.
Antimicrobials, like all drug products, are approved in the United States through the Food and Drug Administration (FDA) and in the European Union partly through the European Medicines Agency (EMEA). This article investigates the differences in approved indications between these 2 bodies for a series of antimicrobial agents approved during the past decade.
The antimicrobial compounds most recently approved for specific indications by both the FDA and EMEA were included in the study. Indications were recorded from the respective Web sites and compared. Differences in approved indications were considered major if one regulatory body approved an agent for treatment of a specific condition while the other did not, or if one regulatory body approved an agent only for prophylaxis while the other approved it also for treatment. Differences were considered minor when the 2 bodies approved an antimicrobial for the same condition or pathogen but with different details regarding specific clinical situations.
Thirteen antimicrobial compounds approved by both the FDA and EMEA were included in the study, namely anidulafungin, caspofungin, dapto-mycin, doripenem, ertapenem, linezolid, micafungin, posaconazole, quinupristin/dalfopristin, retapamulin, telithromycin, tigecycline, and voriconazole. Among these 13 agents, differences in approved indications between the United States and Europe were found to be major for 6 and minor for 6. Approved indications were the same for only 1 agent. Major differences were noted for doripenem, linezolid, micafungin, quinupristin/dalfopristin, posaconazole, and telithro-mycin. Examples of major differences include the following: linezolid has a US indication for vancomycin-resistant Enterococcus faecium infections, but no similar indication in Europe; micafungin is indicated for pediatric use in Europe but not in the United States; and use of posaconazole is primarily therapeutic in Europe but preventive in the United States. Minor differences were noted for anidulafungin, caspofungin, daptomycin, ertapenem, retapamulin, and voriconazole. As an example of a minor difference, daptomycin has different indications for Staphylococcus aureus bacteremia. Tigecycline was the only agent for which the FDA and EMEA had approved identical indications.
Differences in the indications for most antimicrobial agents were found between the United States and Europe. Because any approved indication can be viewed as scientific evidence, these differences may raise legal issues regarding the treatment of specific entities. To minimize these differences, coordination is needed between the FDA and EMEA regarding the procedures for approving indications.
抗菌药物与所有药品一样，在美国需通过食品药品监督管理局（FDA）批准，在欧盟则部分需通过欧洲药品管理局（EMEA）批准。本文调查了过去十年间这两个机构批准的一系列抗菌药物在批准适应症方面的差异。
该研究纳入了最近由FDA和EMEA批准用于特定适应症的抗菌化合物。从各自网站记录适应症并进行比较。如果一个监管机构批准一种药物用于治疗某一特定病症而另一个机构未批准，或者一个监管机构仅批准一种药物用于预防而另一个机构还批准其用于治疗，则批准适应症的差异被视为主要差异。当两个机构批准一种抗菌药物用于相同病症或病原体，但在具体临床情况的细节方面有所不同时，差异被视为次要差异。
该研究纳入了13种由FDA和EMEA都批准的抗菌化合物，即阿尼芬净、卡泊芬净、达托霉素、多利培南、厄他培南、利奈唑胺、米卡芬净、泊沙康唑、奎奴普丁/达福普汀、瑞他帕林、泰利霉素、替加环素和伏立康唑。在这13种药物中，发现美国和欧洲在批准适应症上的差异主要的有6种，次要的有6种。只有1种药物的批准适应症相同。多利培南、利奈唑胺、米卡芬净、奎奴普丁/达福普汀、泊沙康唑和泰利霉素存在主要差异。主要差异的例子如下：利奈唑胺在美国有治疗耐万古霉素屎肠球菌感染的适应症，但在欧洲没有类似适应症；米卡芬净在欧洲有儿科用药适应症，但在美国没有；泊沙康唑在欧洲主要用于治疗，而在美国主要用于预防。阿尼芬净、卡泊芬净、达托霉素厄他培南、瑞他帕林和伏立康唑存在次要差异。作为次要差异的一个例子，达托霉素对金黄色葡萄球菌菌血症有不同的适应症。替加环素是FDA和EMEA批准的适应症完全相同的唯一药物。
发现美国和欧洲在大多数抗菌药物的适应症方面存在差异。由于任何批准的适应症都可被视为科学证据，这些差异可能引发有关特定实体治疗的法律问题。为尽量减少这些差异，FDA和EMEA在批准适应症的程序方面需要进行协调。
