Expansion of the indication and market launch of Pretomanid (Dovprela®) in Germany
Background:
For the treatment of drug-resistant tuberculosis, a 6-month regimen—which is better tolerated than the standard 18-month regimen—has been recommended since 2022 for all rifampicin-resistant (RR) tuberculosis (TB) cases, consisting of the drugs bedaquiline, pretomanid, linezolid, and, depending on the resistance profile, moxifloxacin (BPaL/M) (1). However, according to the European Medicines Agency (EMA) approval indication, pretomanid (Dovprela®)—a necessary component of this combination—was reserved for particularly severe cases of drug-resistant tuberculosis that exhibit additional resistance to isoniazid and fluoroquinolones or in which therapy had failed. To treat RR-TB in accordance with guidelines using BPaLM, pretomanid therefore had to be used off-label until now, and for this reason, some health insurance providers experienced delays in covering outpatient costs.
On February 18, 2026, the EMA expanded the approved indication for pretomanid, so that, in combination with bedaquiline and linezolid, the following cases are now approved for treatment:
• Rifampicin resistance, with or without isoniazid resistance
• Rifampicin resistance and additional fluoroquinolone resistance
This allows for the use of the BPaL/M regimen in accordance with guidelines within the approved indication (2, 3). According to Viatris, Pretomanid is now officially being launched on the German market with the expanded indication. As a privileged reserve antibiotic, the drug is undergoing the AMNOG procedure for early benefit assessment by the Joint Federal Committee (G-BA). Within the first year after market launch, the pharmaceutical company may set the sales price.
Classification for Germany:
The expansion of the approved indication is a major relief for clinical practice, as it will no longer be necessary to provide extensive justification for off-label use in order to ensure the continuation of outpatient therapy following discharge from the hospital. Another barrier to the use of pretomanid is the high cost of the drug, which cannot be covered by the TB flat-rate fees for inpatient treatment. Details regarding the drug’s distribution are not yet known, and it remains to be seen what impact the official launch on the German market will have on pricing.
Related links
https://www.ema.europa.eu/en/medicines/human/EPAR/dovprela#assessment-history
https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/1361/
Reference List
1. World Health Organization. WHO Consolidated Guidelines on Tuberculosis. Module 4: Treatment—Treatment of Drug-Resistant Tuberculosis, 2022 Update. Geneva: World Health Organization. License: CC BY-NC-SA 3.0 IGO. 2022.
2. World Health Organization. WHO Operational Handbook on Tuberculosis. Module 4: Treatment and Care. Geneva: World Health Organization; 2025. License: CC BY-NC-SA 3.0 IGO. 2025.
3. Lange C, Schaberg T, Otto-Knapp R. Update: Treatment of drug-resistant tuberculosis (DR-TB) in Germany, Austria, and Switzerland—Updated recommendations based on the 2025 WHO guidelines. Pneumologie. 2025;79:1–8.
