GARDP welcomes first-ever WHO list of antibiotics to be prioritized for paediatric development

23 March 2023

Geneva, 23 March 2023 – The World Health Organization (WHO) published today the first-ever list of priority antibiotics to be developed for use in infants and children. The list indicates where resources should be concentrated to expedite the development of safe, effective and accessible treatment options for children with bacterial infections, including those significantly impacted by antibiotic resistance. It is the result of a “PAediatric Drug Optimization” (PADO) exercise carried out by WHO and partners in the Global Accelerator for Paediatric formulations (GAP-f) network.

The development of medicines for children trails that for adults by nearly a decade. Bacterial infections, especially pneumonia, neonatal sepsis and gastrointestinal infections, are a significant cause of death among children under age 5 years old worldwide. The PADO list is a significant step forward in identifying and rapidly developing critical antibiotics, dosing and formulations to reduce these deaths.

The PADO priority list of antibiotics for development within 3-5 years includes amoxicillin-clavulanic acid, nitrofurantoin, and azithromycin, which need child-friendly formulations, as well as cefiderocol, which requires development data and evidence for paediatric and neonatal use. The PADO watch list of promising antibiotics for development within 5-10 years includes cefepime-taniborbactam and sulbactam-durlobactam.

Two of the products, cefiderocol and cefepime-taniborbactam, are part of GARDP’s portfolio. Cefiderocol was selected for the PADO priority list because of its efficacy against multiple pathogens on the WHO bacterial priority pathogens list and its ongoing clinical trials with children. It has already been approved in some countries to treat certain infections in adults for which there are limited treatment options. Cefepime-taniborbactam was selected for the watch list on the basis of its efficacy against multiple pathogens on the WHO priority list, its acceptable safety profile, and the potential to expedite studies involving children.

Through a license and technology transfer agreement with Shionogi & Co., Ltd, GARDP has the rights to manufacture and commercialize cefiderocol through sub-licensees in 135 countries, nearly 70% of countries worldwide, including all low-income countries, most middle-income countries, and some high-income countries. Through a collaboration agreement with Venatorx Pharmaceuticals, GARDP is leading the paediatric development of cefepime-taniborbactam. It has the rights to distribute and sub-distribute cefepime-taniborbactam in 64 countries—including the majority of low and lower middle-income countries—as well as the public markets in India and South Africa.

The PADO for antibiotics list was published in a report that outlines additional research priorities. Among them is the investigation of novel combinations of existing antibiotics—including fosfomycin and/or flomoxef—for treating certain types of infections, especially neonatal sepsis, in settings with high levels of drug resistance to currently recommended treatments. GARDP and partners are now launching a trial to rank the safety and efficacy of three such antibiotic combinations—fosfomycin-amikacin, flomoxef-amikacin, and flomoxef-fosfomycin—to treat sepsis in newborns.

GARDP will continue to contribute to efforts by the GAP-f network to advance research and development that targets bacterial infections in children.