Tuberculosis (TB) is a major cause of illness and death among children in low- and middle-income countries, but the current TB drug regimens to treat them are inadequate. To improve treatment and reduce mortality among children with TB, UNITAID has provided TB Alliance a three-year grant to accelerate the availability of properly formulated pediatric TB regimens.
“Despite the urgent need for child-friendly TB formulations, market barriers to innovation remain a challenge,” said Dr. Philippe Douste-Blazy, UNITAID Chair of the Executive Board. “By providing this grant UNITAID will help forge a healthy, dynamic, and sustainable market for quality-assured pediatric TB medicines.”
TB is a leading killer of children, particularly in resource-poor settings, though the true size of the problem is unknown. Estimates of the number of children who contract TB annually range from 300,000 up to 1 million; more than 60,000 die each year but many deaths go unreported, especially in high-burden TB countries. In 2010, the World Health Organization (WHO) revised its recommended dosages for first-line pediatric TB drugs. However today, there are still no TB drugs for children in the correct dosage forms.
UNITAID’s grant provides TB Alliance with up to US $16.7M to facilitate the development and adoption of appropriate formulations for pediatric TB medicines for both existing and future TB treatments. The US Agency for International Development is also contributing to this initiative by leveraging resources to ensure that this initiative will be successful.
“This is an opportunity to address a long neglected need,” said Dr. Mel Spigelman, President and CEO, TB Alliance. “We can now—in a very rapid way—improve the state of children’s TB treatment by reformulating today’s available drugs. Simultaneously, we will also work to dramatically reduce the timeline needed to introduce pediatric formulations of the shorter, simpler, and faster TB regimens now advancing through the pipeline.”
As part of the grant, TB Alliance, working with WHO and other partners, will undertake a pediatric TB knowledge-sharing initiative. This initiative will give manufacturers and other stakeholders ready access to important information to address a range of scientific, regulatory, access, and market challenges relevant to children. The development of new TB treatments paired with this market intelligence is intended to lower the barriers for manufacturers, which can then produce these medicines on a sustainable basis.
“There are tremendous gaps in the pediatric TB medicine market, and providers today have poor options to help children suffering from tuberculosis,” said Dr. Mario Raviglione, Director of the Stop TB Department, WHO. “As a partner and collaborator on this grant, we will address those gaps and do all we can to improve treatment for children in need. We want zero TB deaths and suffering in children.”
The grant outlines a multi-pronged approach to achieve increased availability of properly formulated TB regimens for children. Part of that approach includes defining the market size for pediatric TB, clarifying the pathway to regulatory approval of child-specific product formulations in regions around the world, and incentivizing manufacturers to participate in the production of child-appropriate formulations of existing TB drugs. This work will lay the foundation for the streamlined development of pediatric formulations of new TB drugs, which will improve the difficult treatment through shorter, simpler, and affordable TB regimens to treat and prevent drug-sensitive and drug-resistant TB.
“Forcing children and families to ‘make do’ with the current treatment is untenable—especially when so many children suffer from tuberculosis ,” said Anneke Hesseling, MD, PhD, director of the Pediatric TB Research group at the Desmond Tutu TB Centre, Stellenbosch University in South Africa. “This grant gives the pediatric research community hope for the future. We look forward to global partnerships to realize the full potential of this exciting project.”
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About TB Alliance:
The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, Irish Aid, UK aid, UNITAID, National Institute of Allergy and Infectious Disease, the United States Agency for International Development, and the United States Food and Drug Administration. For more information, please visit tballiance.org.
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