News 2025

Pretomanid is currently approved by the EMA for use only in combination with bedaquiline and linezolid (BPaL regimen) and restricted to cases of extensively drug-resistant (XDR) and select MDR-TB patients. However, global evidence from recent clinical trials—including NiX, ZeNix, and TB-PRACTECAL—demonstrates the effectiveness of an expanded regimen, BPaLM (including moxifloxacin), as the new standard of care for MDR/RR-TB. The WHO has recommended its programmatic use since 2022, urging national TB programs to adopt these regimens swiftly.

Despite these advancements, access to pretomanid remains limited in Europe. Expanding pretomanid’s label will ensure more patients benefit from shorter, safer, and more effective TB treatment.

This expert coalition proposes to EMA to act swiftly, updating pretomanid’s label to align with WHO recommendations and ensure equitable access to life-saving treatments across Europe.

“Updating the EMA label for Pretomanid will be important to overcome problems of access to Pretomanid that currently exist in Europe. The coalition of many professional societies in Respiratory Medicine and Infectious Diseases endorsing this open letter shows the importance of this problem”, says Professor Christoph Lange from the Clinical Tuberculosis Unit of the German Center of Infection Research (DZIF) and Medical Director of the Research Center Borstel, co-organizer of this initiative.

Publication:

Kuksa L, Andrejak C, Haecker B, Bothamley G, Calcagno A, Cirillo D, Duarte R, Fatima R, Ferlazzo G, Guglielmetti L, Günther G, Hewison C, Horsburgh CR, Jäger T, Kalancha Y, Otto-Knapp R,. Kranzer K,Lillebaek T, Marks G, Middlekoop K, Motta I, Rabinova V, Sommerfeld VP, Tattevin P, Lange C. Urgent request for pretomanid label expansion to align with WHO guidelines and improve treatment accessibility and efficacy. IJTLDopen, Volume 2, Number 3, 1 March 2025, pp. 117-119(3) DOI: https://doi.org/10.5588/ijtldopen.25.0152

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