L Kuksa, C Andrejak, B Haecker, G Bothamley, A Calcagno, D M Cirillo, R Duarte, R Fatima, G Ferlazzo, L Guglielmetti, G Günther, C Hewison, C R Horsburgh, T Jäger, Y Kalancha, R Otto-Knapp, K Kranzer, T Lillebaek, G Marks, K Middelkoop, I Motta, V Rabinova, P Sommerfeld, P Tattevin, C Lange
{"title":"Urgent request for pretomanid label expansion to align with WHO guidelines and improve treatment accessibility and efficacy.","authors":"L Kuksa, C Andrejak, B Haecker, G Bothamley, A Calcagno, D M Cirillo, R Duarte, R Fatima, G Ferlazzo, L Guglielmetti, G Günther, C Hewison, C R Horsburgh, T Jäger, Y Kalancha, R Otto-Knapp, K Kranzer, T Lillebaek, G Marks, K Middelkoop, I Motta, V Rabinova, P Sommerfeld, P Tattevin, C Lange","doi":"10.5588/ijtldopen.25.0152","DOIUrl":null,"url":null,"abstract":"<p><p>Pretomanid is a key anti-TB drug included in the WHO list of essential medications. The current EMA-approved label for pretomanid restricts its use to the regimen comprising bedaquiline, pretomanid and linezolid (BPaL) and only for extensively drug-resistant-TB or multidrug-resistant TB, \"when antibiotics used for the latter form of TB do not work or cause unacceptable side effects.\" This restricted use implies that the older, prolonged and poorly tolerated regimens remain the recommended treatment for most cases of drug-resistant TB. The authors, representing many respiratory groups and societies, call for the label expansion of pretomanid to align with global guidelines, allowing for broader use.</p>","PeriodicalId":519984,"journal":{"name":"IJTLD open","volume":"2 3","pages":"117-119"},"PeriodicalIF":0.0000,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11906023/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"IJTLD open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5588/ijtldopen.25.0152","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Pretomanid is a key anti-TB drug included in the WHO list of essential medications. The current EMA-approved label for pretomanid restricts its use to the regimen comprising bedaquiline, pretomanid and linezolid (BPaL) and only for extensively drug-resistant-TB or multidrug-resistant TB, "when antibiotics used for the latter form of TB do not work or cause unacceptable side effects." This restricted use implies that the older, prolonged and poorly tolerated regimens remain the recommended treatment for most cases of drug-resistant TB. The authors, representing many respiratory groups and societies, call for the label expansion of pretomanid to align with global guidelines, allowing for broader use.
普托莫尼是一种关键的抗结核药物，已被列入世界卫生组织的基本药物清单。目前 EMA 批准的普利托马尼标签将其限制用于由贝达喹啉、普利托马尼和利奈唑胺（BPaL）组成的治疗方案，并且只用于广泛耐药结核病或耐多药结核病，"当用于后一种结核病的抗生素不起作用或产生不可接受的副作用时"。"这种限制性使用意味着，对于大多数耐药性肺结核病例，仍建议使用较老的、疗程长且耐受性差的治疗方案。作者代表许多呼吸系统团体和学会，呼吁扩大普托玛尼的标签范围，使其与全球指南保持一致，从而允许更广泛的使用。
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