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TB Alliance to Develop Pediatric TB Drugs With Support From UNITAID

By Citizen News Service

Tuberculosis (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. Yet the the current TB drug regimens to treat them are inadequate.

In 2010, the World Health Organization (WHO) revised its recommended dosages for first-line pediatric TB drugs. However, till today there are no TB drugs for children in the correct dosage forms. With a view to reshape market forces, and catalyze development to improve treatment and reduce mortality among children with TB, UNITAID has provided the Global Alliance for TB Drug Development (TB Alliance) a three-year grant to accelerate the availability of properly formulated pediatric TB regimens.

Dr. Philippe Douste-Blazy, UNITAID Chair of the Executive Board, said that, "By providing this grant UNITAID will help forge a healthy, dynamic, and sustainable market for quality-assured pediatric TB medicines."

UNITAID's grant provides TB Alliance with up to US $16.7 million to facilitate the development and adoption of appropriate formulations for pediatric TB medicines for 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.

The grant outlines a multi-pronged approach to achieve increased availability of properly formulated TB regimens for children. A 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 will also lay the foundation for the streamlined development of pediatric formulations of new TB drugs, which will improve the current difficult treatment through shorter, simpler, and affordable TB regimens to treat and prevent drug-sensitive and drug-resistant TB.

"This is an opportunity to address a long neglected need," said Dr. Mel Spigelman, President and CEO, TB Alliance to Citizen News Service - CNS. "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, along 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, who can then produce these medicines on a sustainable basis.

"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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