The DCGI (Drug Controller General of India) approved TB drug, pretomanid, for conditional access under the National Tuberculosis Elimination Program (NTEP), can play a significant role towards elimination of highly drug-resistant TB in India
The world continues to battle against pandemics, including COVID-19 and tuberculosis (TB). March 24, marks World TB Day and TB Alliance is joining with partners around the globe to raise awareness of one of the world’s oldest diseases. TB had been the world’s leading infectious killer until COVID-19. This new pandemic has shown that new tools, diagnostics, drugs, and vaccines can be quickly developed and deployed with the adequate funding and political will. The same resources are needed to bring the TB pandemic under control and make progress toward a TB-free world.
In July 2020, the Drug Controller General of India (DCGI) had approved the TB drug pretomanid (developed specifically for certain drug-resistant forms of the disease) for conditional access under the National Tuberculosis Elimination Program (NTEP), making India the second country in the world to provide regulatory approval for this product.
On the occasion of World TB Day, Sandeep Juneja, Sr. VP, Market Access at TB Alliance, said “New regimens are urgently needed to treat this deadly infectious disease, especially drug-resistant forms of TB which have a history of poor cure rates and treatments with often intolerable side effects. We welcome the fact that more than 30 countries, including India, have obtained pretomanid-based regimens to treat highly drug-resistant forms of TB. TB Alliance stands ready to work side by side and learn from India and every other country seeking to implement new TB therapies. Our job is not done until each treatment we develop is accessible to every person who needs it.”
A government-led study of the regimen in India called *mBPaL commenced in October 2021 and is now enrolling patients at three sites out of a planned 11. It is scheduled to reach its primary completion in 2023 after enrolling 400 patients.
TB Alliance manages the largest portfolio of TB drug candidates, with more than 30 projects under active development. Its researchers and research partners are working to advance the development of new TB compounds and medicines, with a goal to develop a short, simple, and affordable TB regimens suitable for all people with TB.
To date, 17 countries or regulatory bodies, including India, have approved pretomanid as part of the BPaL regimen for the treatment of patients with highly drug-resistant forms of TB. Regulatory applications have been submitted to another 13 countries and counting by Viatris, TB Alliance’s global commercialization partner for pretomanid as part of the regimen. Viatris is joined by Macleods, Lupin, and Hongqi Pharma in holding licenses for pretomanid in countries with high TB burdens.
Data from TB Alliance’s ZeNix trial of the BPaL regimen, presented in 2021, demonstrated improvement in the safety and tolerability of the BPaL regimen with alterations in linezolid dosing with sustained favorable outcomes in 89 precent of all participants. Though important advances have been made in recent years, the need to invest in TB research and development is even more apparent amidst the COVID-19 pandemic, which has already reversed hard-won progress against TB. In 2020, the world saw the first increase in TB deaths since 2005, and a 15 percent reduction in the number of people treated for drug-resistant TB.
Bringing the TB pandemic under control can only be realised through global commitment and collaboration. TB Alliance aims to contributing to this aspiration by inventing novel therapies that radically reshape the treatment landscape and save lives.
*BPaL regimen combines the antibiotics bedaquiline (B), pretomanid (Pa) and linezolid (L)
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