Experts are calling for an urgent expansion of the approval of pretomanide.

27.03.2025 17:42

A coalition of leading tuberculosis experts and medical societies, including the German Center for Infection Research (DZIF), is calling for an urgent extension of the European Medicines Agency's (EMA) approval for pretomanid, a key drug in the fight against multidrug-resistant tuberculosis (MDR-TB) and rifampicin-resistant TB (RR-TB).

This appeal is being published to coincide with World Tuberculosis Day on March 24 and is in line with the latest guidelines from the World Health Organization (WHO). It aims to improve patients' access to more effective and tolerable treatment methods.

Pretomanid is currently authorized by the EMA only in combination with bedaquiline and linezolid (BPaL regimen) and is restricted to extensively drug-resistant (XDR) and selected MDR-TB patients. However, global data from recent clinical trials – including NiX, ZeNix, and TB-PRACTECAL – demonstrate the efficacy of an expanded regimen, BPaLM (including moxifloxacin), as a new standard of care for MDR/RR-TB. The WHO has recommended the programmatic use of this regimen from 2022 onwards and urged national tuberculosis programs to implement it rapidly.

Despite these advances, access to pretomanid remains limited in Europe. Expanding the marketing authorization for pretomanid will ensure that more patients benefit from a shorter, safer, and more effective tuberculosis treatment.

The expert coalition proposes that the EMA act swiftly and update the marketing authorization for Pretomanid to align it with WHO recommendations and ensure equal access to life-saving treatments across Europe.

„Updating the EMA label for pretomanid is crucial to overcoming the current access problems for pretomanid in Europe. The coalition of many respiratory and infectious disease societies supporting this open letter demonstrates the importance of this issue,“ says Prof. Christoph Lange from the Research Center Borstel, Leibniz Lung Center, scientist in the „Tuberculosis“ research unit of the German Center for Infection Research (DZIF) and corresponding author of this initiative.