TB Alliance is committed to ensuring access to pretomanid as part of a TB treatment regimen.
Pretomanid is a tuberculosis (TB) drug developed by TB Alliance for the treatment of highly drug-resistant TB for use in combination with bedaquiline and linezolid – collectively known as the BPaL regimen. The regimen received its first regulatory approval in August 2019 and availability and accessibility has continued to spread around the world.
Use the tool below to find details on accessibility in any country, either in terms of regulatory approval, or access through the Named Patient Access Program (NPAP) through partnership with Viatris, through the The Stop TB Partnership’s Global Drug Facility (GDF) catalog of TB medicines, or through ongoing operational research or similar projects in specific countries. Clicking on a country's name will open the World Health Organization's TB profile for that country.
PATHWAYS TO ACCESS:
- Regulatory approval of BPaL is indicated in countries where the regimen was reviewed and approved by a regulatory authority, for example the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) or the Drug Controller General of India (DCGI).
- The NPAP is designed for patients in countries where regulatory approval or other access mechanisms for BPaL are not yet available. TB Alliance’s commercialization partner Viatris launched the program in May 2020. More information is available here.
- Listing in the GDF catalogue of TB medicines ensures that the treatment course will be available to 150 countries representing the vast majority of the global TB burden. More information is available here.
- In specific countries, TB Alliance is working with clinicians to implement the BPaL regimen under operational research settings. These efforts are underway in various parts of the world to help increase access to TB treatment options.
- GDF
- GDF
- Regulatory Approval
- Regulatory Approval
- NPAP
- GDF