Following US FDA approval, child-friendly bedaquiline available from Stop TB Partnership's GDF Pediatric DR-TB Initiative
11 June 2020, Geneva, Switzerland– The Stop TB Partnership’s Global Drug Facility (GDF) today announced the addition of child-friendly bedaquiline 20 mg tablets to the GDF Pediatric DR-TB Initiative. The US FDA approval of the medicine, on 27 May 2020, marks a new milestone for all-oral DR-TB regimens in children who are older than 5 years of age and weighing more than 15 kilograms. These children will now benefit from the same optimized treatments being provided to their parents – no more injections for anyone.
When procured via GDF, a six-month treatment course of child-friendly bedaquiline costs USD 200 for children 5-12 years of age, bringing the total cost of a 5-drug, 12-month DR-TB regimen* to approximately USD 1,175.
All countries can procure medicines via GDF, regardless of funding source, in line with national regulations. The 2018 UN Political Declaration on the Fight against TB states, “We, Heads of State and Government and representatives of States and Governments […] encourage all nations to use the Stop TB Partnership/Global Drug Facility.”
The GDF Pediatric DR-TB Initiative – funded by the Government of Japan and the United States Agency for International Development – has already expedited access to other child-friendly DR-TB medicines and regimens, plus delamanid, in more than 50 countries.
The addition of pediatric bedaquiline to this Initiative brings the total number of child-friendly DR-TB medicines supplied by GDF to nine – a remarkable feat in a fragile pediatric DR-TB market where children account for only 5% of DR-TB cases.
GDF’s end-to-end approach in the Initiative addresses bottlenecks for both TB programs and suppliers to ensure the best products get to kids as quickly as possible. GDF’s pooled procurement and production planning help to balance supply and demand – ensuring TB programs meet minimum order requirements no matter how many kids are being treated and decreasing waste and transaction costs for suppliers. GDF is providing complementary technical assistance on quantification and supply planning plus the funding for the procurement of medicines and is working closely with the Sentinel Project and other partners who provide technical assistance on specific country treatment recommendations and guidelines.
“For all of us to understand that TB suppliers and GDF have brought forward optimized formulations and a mechanism to accelerate the uptake of child-friendly formulations by National TB Programs. I now call upon the entire global TB community for a renewed focus to find, diagnose, and treat all the children with DR-TB if we have any hope to meet the UNHLM target of treating 115,000 children with DR-TB by 2022,” said Dr. Lucica Ditiu, Executive Director, Stop TB Partnership.
- For ordering information on pediatric bedaquiline, delamanid, and other TB medicines, please see the GDF Catalog
- For more information on the GDF Pediatric DR-TB Initiative, please see the GDF webpage
- For information on the FDA approval of pediatric bedaquiline, please see the FDA website
- For WHO DR-TB Treatment Guidelines, please see the WHO website
- For more information on the treatment of pediatric DR-TB, please see the Sentinel Field Guide
*5-drug regimen used in cost estimate is 6 Bdq Lfx Lzd Cfz Cs/6 Lfx Lzd Cfz Cs using doses for children 6 years or older and weighing 16-23 kgs.
Source: Stop TB Partnership