WHO releases priorities for research and development of age-appropriate antibiotics

The lack of investment and poor clinical trial infrastructure for antibiotic research in general, and in particular for studies undertaken in children, further exacerbates the situation. The annual WHO pipeline analysis shows a decline in the number antibiotics under development from 31 in 2017 down to 27 in 2021 [2]. In the preclinical stage – before clinical trials can start – the number of products has remained relatively constant over the last 3 years [3].

Across disease areas, the development of medicines for children lags unacceptably behind that for adults by nearly a decade [4] due to limited investments and lack of market incentives among other reasons.  Following the resolution at the 69th World Health Assembly on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, WHO and partners in the Global Accelerator for Paediatric Formulations Network (GAP-f) have increased their efforts to deliver on this global commitment and have scaled up activities to ensure that age-appropriate formulations are available for children [5].

“Priority-setting is the first step to enable a more targeted and efficient approach to research and development,” says Prof John Reeder ai Chief Scientist at WHO. Developing a prioritized medicine portfolio of the most needed formulations for children is essential to streamline researchers’ and suppliers’ efforts and resources around formulations that address the most urgent needs for children. Today appropriate paediatric formulations are generally lacking across the entire clinical pipeline [2].

WHO’s PADO work [6] to identify key priority products and their preferred product characteristics for research and development has been successfully undertaken for HIV, hepatitis C and tuberculosis, demonstrating their potential and impact to accelerate access to optimal formulations in the context of fragmented, small markets for medicines for children.

The PADO list for antibiotics launched today includes a priority list with three legacy antibiotics that already have a paediatric indication but for which an optimal formulation is missing: amoxicillin-clavulanate, azithromycin and nitrofurantoin. Additionally, cefiderocol, a reserve antibiotic for the treatment of infections caused by multidrug-resistant bacteria in adults, is still under investigation for use in infants and children. Two antibiotics, cefepime-taniborbactam and sulbactam-durlobactam, were included in the PADO watch list to promote the faster investigation of these promising products as clinical development in adults progresses. Key research priorities to inform the development and use of these antibiotics were also identified and are summarized in the meeting report that can be found here.

Urgent and concerted investment in research and development of better paediatric formulations of priority antibiotics is needed to accelerate actions towards more equitable access to appropriate treatment for bacterial infections globally.