Presentation (CTI)

OBJECTIVES: Antibiotic resistance is currently one of the greatest threats to global health, linked to misuse and overuse of antibiotics. Development of new antibiotics is challenging due to research obstacles, financial, and regulatory hurdles and, until recently, a lack of incentives for pharmaceutical companies, with a high risk of failure in antibiotic development. This research aimed to assess and compare the trends in approvals of antibiotics by the United States (US) Food and Drug Administration (FDA) and European Medicines Agency (EMA), alongside an analysis of planned or implemented industry incentives, highlighting their potential benefits and drawbacks.
METHODS: FDA and EMA websites were screened for antibiotics approved since 2015 (i.e. the past 10 years) and used for treatment of bacterial infections. A descriptive analysis was conducted using information extracted from FDA and EMA websites. Supplementary desk research was conducted to gather information on planned or introduced industry incentives, focusing on their benefits and drawbacks.
RESULTS: The database search identified fewer antibiotic approvals in the last decade compared with historical trends, with more approved by the FDA than the EMA. Acute bacterial skin and skin structure, complicated urinary tract, and intra-abdominal infections were the most frequent indications for which antibiotics were approved. Antibiotics targeted a range of bacterial pathogens including Pseudomonas aeruginosa and Enterobacteriaceae, which are included on the World Health Organization’s critical pathogen list for research and development of new antibiotics. Several industry incentives were found, including the United Kingdom’s implemented subscription model and the not yet enacted US PASTEUR Act.
CONCLUSIONS: The research revealed a low number of antibiotic approvals, with differences between the US and Europe over the last decade. Several antibiotics targeted critical pathogens, while multiple others remain without effective treatment options. While innovative incentives show promise, tackling antibiotic resistance requires strong global collaboration and sustained investments.