Shorter, Faster, Better!
15 August 2019 I Geneva, Switzerland. The Stop TB Partnership welcomes FDA approval of pretomanid when used with bedaquiline and linezolid: a new three-drug, six-month, all-oral “BPaL” treatment regimen for “highly resistant forms of TB”
The announcement1 of US FDA Approval of a new TB drug, pretomanid, as part of a “BPaL” regimen marks a significant milestone in the fight against TB. The BPaL regimen contains bedaquiline, pretomanid, and linezolid, and provides the TB community with a new, short, all-oral regimen with an FDA indication for treatment of extremely drug-resistant (XDR) TB and those who have failed or are intolerant to multidrug-resistant (MDR) TB regimens. This is a momentous achievement and we commend the TB Alliance who led the research, as well as the National TB Programs and TB researchers who conducted the research in collaboration with the TB Alliance.
We look forward to the World Health Organization (WHO) for rapid assessment of BPaL research findings, along with data from other research trials on shorter, all-oral, DR-TB regimens, followed by a rapid communication in order to ensure that new treatments get to those who need them as quickly. Further, we look forward to the expansion of the current XDR, MDR-failure and MDR-intolerant indication once evidence to support use in treatment of all MDR-TB, including in pregnant women and children, is available.
We have now a unique opportunity to launch the BPaL regimen at an affordable price, make it easily accessible and quickly establish generic competition given the research and development was conducted with grant and public funds by a non-profit, product development partnership.
The Stop TB Partnership teams stand ready to support an expedited introduction of new regimens with activities that include: high-level advocacy for financing and new regimen adoption, in-country programmatic technical assistance, TB Reach pilot projects, Global Drug Facility (GDF) medicines and diagnostics procurement, and GDF technical assistance for phasing out old regimens and phasing in new regimens.
“It is exciting!” says Dr Lucica Ditiu, Executive Director of the Stop TB Partnership. “Some 10 years ago we were dreaming of these moments, and here we are – we have a new, short, all-oral regimen that can significantly improve treatment success in people with “highly resistant forms of TB”. My hope is that we will rapidly move to another level and have country programs conducting research towards using this regimen in all people with MDR-TB. I am convinced we can do this, because this can take us at a different level, in terms of scale and impact!”
The UN High-Level Meeting targets agreed by member states in 2018 call for successfully treating 1.5 million people with DR-TB by 2022. We are strengthened with the number of research studies to be completed over the next few years and the potential number of new tools that will come from this research. We call on all stakeholders and partners to play their part in ensuring these new tools reach those in need. Only by working together – swiftly – will we reach the UNHLM targets and end TB.
Watch this space!
Next week, The Stop TB Partnership will answer a set of FAQs on this new regimen.
About DR-TB and Pretomanid:
Drug-resistant TB is a form of TB that does not respond to the standard antimicrobial drugs. Global cases of drug-resistant TB continue to increase, with more than half a million cases reported in 2017 and an estimated 127 countries reporting cases of XDR-TB, an even more serious form of drug- resistant TB. Historically, drug-resistant forms of TB have been difficult to treat, and the WHO has reported estimates for treatment success of people with XDR TB at approximately 34%.
Pretomanid is the third new drug approved by a stringent regulatory authority in the past decade and the second drug in a class of medicines called nitroimidazoles. The pivotal data on safety and efficacy for pretomanid comes from an open-label trial called Nix-TB. The US FDA granted pretomanid priority review status to expedite the review process, as well as orphan drug status. The US FDA awarded TB Alliance a Tropical Disease Priority Review Voucher that aims to incentivize development of new drugs for the prevention and treatment of certain tropical diseases. 1
1. US Food & Drug Administration. Aug 14, 2019. FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs. FDA News Release. Retrieved Aug 15, 2019 from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-resistant-forms-tuberculosis-affects-lungs