Accelerating Access for Patients
In the year since the first regulatory approval for a three-drug, six-month, all-oral regimen to treat highly resistant TB, TB Alliance and partners have worked to accelerate the global approval and accessibility of this new tool to appropriate patients in the fight against TB. Highlights in the effort to expand global access to pretomanid over the past year include:
- Listing in the Stop TB Partnership’s Global Drug Facility (GDF) ensured availability in 150 low- and middle-income counties.
- The WHO issued new guidelines recommending the regimen under operational research conditions.
- Enrollment was completed in TB Alliance’s Phase 3 ZeNix and SimpliciTB clinical trials evaluating new combination regimens.
- Received approval from the Drug Controller General of India (DCGI) for conditional access under the National Tuberculosis Elimination Program.
- Received marketing authorization from the European Commission.
- The LIFT-TB (Leveraging Innovation for Faster Treatment of Tuberculosis) initiative was launched to broaden adoption of the regimen, targeting seven countries across Southeast and Central Asia.
- Ukraine and Tajikistan provided access to the new treatment regimen through operational research conditions for highly resistant TB patients.
- Funded by the United States Agency for International Development (USAID), a new clinical access program will enroll 400 people in South Africa for treatment with the three-drug, six-month, all-oral regimen.
Realizing Global Accessibility through Patient Access Program
In May 2020, TB Alliance’s commercialization partner Viatris (formerly called Mylan) launched a Named Patient Access Program (NPAP) to provide access to pretomanid for use as part of a three-drug, all-oral regimen and to help ensure that physicians can consider the drug as a viable treatment option for patients, regardless of where they live. With national registrations underway around the world, the NPAP is designed for patients in countries where regulatory approval or other access mechanisms are not yet available. To learn more about this program or to apply, please visit: www.accesspretomanid.com.
Ensuring Availability through Partnerships
Within five months of receiving approval for a TB treatment, TB Alliance had secured commercialization agreements with three partners to ensure that the regimen is accessible and available around the world. The partners include: Viatris (formerly Mylan), Macleods, and Hongqi Pharma. Multiple manufacturing partnerships will help facilitate global coverage of TB markets and further promote competitive and sustainable pricing. In addition to these agreements, the Stop TB Partnership’s Global Drug Facility included the new treatment in its product catalog, helping to ensure global access to those in need.
Research to BENEFIT Kids
It is estimated that about 2 million children are infected with DR-TB and more than 30,000 become sick with active DR-TB each year. While TB Alliance led the introduction of child-friendly medicines available to treat drug-susceptible TB, there remain critical gaps in the availability of medicines designed for children with DR-TB. This results in suboptimal treatment options, putting children at risk for substantially preventable morbidity and mortality. Stellenbosch University has organized a comprehensive network of partners to help address these availability gaps in key second-line medicines for children under the BENEFIT Kids Project (Better Evidence and Formulations for Improved MDR-TB Treatment for Children), funded by Unitaid. TB Alliance is contributing to the BENEFIT Kids project by stimulating progress, partnering with generic manufacturers, and ensuring development of novel child-friendly medicines or optimized formulations suitable for administering to children.
TB Alliance, in partnership with ITRC, KOICA and KNCV, announced an initiative to broaden adoption and scale up of new TB treatment regimens. This initiative, known as LIFT-TB, will also seek to increase treatment completion rates for drug-resistant forms of TB in some of the countries most affected by this form of TB across the Southeast and Central Asian regions, namely Indonesia, Myanmar, the Philippines, Vietnam, Kyrgyzstan, Ukraine, and Uzbekistan.