The time is now: making the case for compassionate use/pre-approval access to new TB drugs

Although the majority of people with multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) can now be successfully treated with all-oral shorter regimens, rising rates of resistance to the components in these regimens are a growing global challenge. The drug development pipeline for TB has more novel compounds in phase 2 trials than ever before, and accessing these agents through systematic compassionate use programmes is an ethical and public health imperative. There is more than a decade of successful experience with compassionate use for MDR/RR-TB, resulting in benefits for people with MDR/RR-TB, novel chemical entity developers, providers, and programmes. Although there are some arguments for delaying access to the new TB drugs in the pipeline, we present reasons why such access should be an urgent priority for all TB stakeholders.

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Publication Details

Journal
IJTLD OPEN
Published
2025-12-01
DOI
https://doi.org/10.5588/ijtldopen.25.0644
Citations
1
Primary Topic
Biomedical Ethics and Regulation
Type
article
Field-Weighted Citation Impact
1.16
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article

The time is now: making the case for compassionate use/pre-approval access to new TB drugs

Tom Decroo, Pauline Howell, Jennifer Furin, Lorenzo Guglielmetti et al.
1 citations
IJTLD OPEN
Biomedical Ethics and Regulation
1.16
article

The time is now: making the case for compassionate use/pre-approval access to new TB drugs

Tom Decroo, Pauline Howell, Jennifer Furin, Lorenzo Guglielmetti, Jonathan Stillo, Lia D’Ambrosio, Giovanni Battista Migliori, Anita Mesić, Sein Sein Thi, Anja Reuter, Irene Motta, M. Mbenga, Agnes Gebhard
article en
1 citations

Abstract

Although the majority of people with multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) can now be successfully treated with all-oral shorter regimens, rising rates of resistance to the components in these regimens are a growing global challenge. The drug development pipeline for TB has more novel compounds in phase 2 trials than ever before, and accessing these agents through systematic compassionate use programmes is an ethical and public health imperative. There is more than a decade of successful experience with compassionate use for MDR/RR-TB, resulting in benefits for people with MDR/RR-TB, novel chemical entity developers, providers, and programmes. Although there are some arguments for delaying access to the new TB drugs in the pipeline, we present reasons why such access should be an urgent priority for all TB stakeholders.

IJTLD OPENVol. 2(12)
Harvard University (US), Wayne State University (US), University of the Witwatersrand (ZA), Stellenbosch University (ZA), Koninklijke Nederlandse Chemische Vereniging (NL), Istituti Clinici Scientifici Maugeri (IT), Ospedale Sacro Cuore Don Calabria (IT), Médecins Sans Frontières (NL), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Ministry of Health (SZ), Instituut voor Tropische Geneeskunde (BE)
Openalex Percentile: Top 16%
Biomedical Ethics and Regulation
1.16
DOIOpen Access PDFOpenAlex
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