Urgent request for pretomanid label expansion to align with WHO guidelines and improve treatment accessibility and efficacy.

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.

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Publication Details

Journal
Open Access CRIS of the University of Bern
Published
2025-03-01
DOI
https://doi.org/10.48620/86973
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
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article

Urgent request for pretomanid label expansion to align with WHO guidelines and improve treatment accessibility and efficacy.

Open Access CRIS of the University of Bern
Tuberculosis Research and Epidemiology
article

Urgent request for pretomanid label expansion to align with WHO guidelines and improve treatment accessibility and efficacy.

article en

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.

Open Access CRIS of the University of Bern
University Clinic of Pulmonary and Allergic Diseases Golnik (SI)
Good health and well-being
Openalex Percentile: Top 50%
Tuberculosis Research and Epidemiology
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