Paediatric populations (newborns, infants and children) are particularly vulnerable to growing antimicrobial resistance (AMR). In Europe, drug-resistant infections are responsible for an estimated 2300 disability-adjusted-life-years (DALYs) per 100,000 people every year- the majority in infants under 1-year-old. The problem is expected to be higher still in many low-and-middle-income countries (LMICs). The AMR crisis is exacerbated by a lack of new antibiotics in development and paediatric patients are particularly affected. Treatments for neonates, infants and children need to be adapated to their specific needs, including the formulation and dosing of antibiotics. At present, if it happens at all, it takes around seven years for the evidence base for antibiotics used in adults to be adapted for paediatric patients.
GARDP’s paediatric antibiotic programme aims to expedite the development of new, improved and adapted antibiotics to treat serious bacterial infections in children of-all-ages. With a global focus, the programme aims to develop antibiotics for countries with a high burden of drug-resistance for use in hospitals and the community in both LMIC and high-income settings.
Objectives, by 2023
GARDP is developing a paediatric investigation plan to facilitate initial registration of an antibiotic called polymyxin B in Europe, particularly in Italy and Greece, followed by other regions with a high burden of drug-resistance, including in Africa and Asia. GARDP has also started a collaboration with Novartis’ generic division, Sandoz, to accelerate the development and availability of antibiotic treatments for children in low and middle-income settings.
A snapshot of the programme
- Märkische Online Zeitung: “Tödlichere Gefahr als der Terrorismus” 5 September 2017
- Stern: “56 Millionen für neu entwickelte Medikamente bis 2022” 4 September 2017
- Telegraaf: “Twee miljoen euro voor nieuwe antibiotica” 4 September 2017
- Ärzte Zeitung: “56 Mio. Euro für die Bekämpfung von Antibiotika-Resistenzen” 4 September 2017
- Märkische Online Zeitung: “Mehr als 56 Millionen Euro für die Antibiotikaforschung” 4 September 2017
Consumption of oral antibiotic formulations for young children according to the WHO Access, Watch, Reserve (AWaRe) antibiotic groups: an analysis of sales data from 70 middle-income and high-income countries. The Lancet Infectious Diseases, December 2018
by Hsia Y, Sharland M, Jackson C, Wong ICK, Magrini N, Bielicki JA.
 European Medicine Agency (EMA) definitions – newborns including neonates: up to 28-days, infants and toddler: up to 23-months, children 2-11 years-old, adolescents 12 years-old -16-18- years old, depending on region
 Disability-adjusted-life-years are a measurement of overall disease burden of years of healthy life lost through ill-health, disability or early death. More information
 Cassini, A. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis” The Lancet Infectious Diseases 2018, doi: 10.1016/S1473-3099(18)30605-4
 A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in paediatric populations to support the authorisation of a medicine for use in children and infants. Source