Geneva, June 14, 2024 – The World Health Organization (WHO) has released its latest report on antibacterial agents, revealing a concerning gap in the development of innovative treatments for serious infections amid the growing threat of antimicrobial resistance (AMR). Despite an increase in the number of antibacterial agents in the clinical pipeline from 80 in 2021 to 97 in 2023, the report underscores an urgent need for new, innovative solutions to replace those becoming ineffective due to widespread use.
First introduced in 2017, this annual report assesses whether the current research and development (R&D) pipeline addresses infections caused by drug-resistant bacteria identified in the 2024 WHO bacterial priority pathogen list (BPPL). Both the report and the BPPL aim to guide antibacterial R&D efforts to better tackle the escalating threat of AMR.
AMR arises when bacteria, viruses, fungi, and parasites no longer respond to medicines, leading to increased severity and spread of infections, higher illness and death rates. Misuse and overuse of antimicrobials are major drivers of AMR, yet access to essential antimicrobial medicines remains inadequate for many around the world.
“Antimicrobial resistance is worsening, but our development of new, groundbreaking products is lagging,” said Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Antimicrobial Resistance ad interim. “Even when new products are authorized, access is a significant challenge. Antibacterial agents are not reaching the patients who desperately need them, across all income levels.”
The report highlights several critical issues:
- Innovation Deficit: Out of 32 antibiotics under development to address BPPL infections, only 12 are innovative. Furthermore, only 4 of these 12 target at least one WHO ‘critical’ pathogen, the highest risk category in the BPPL.
- Pipeline Gaps: There are significant gaps in the pipeline, including products for children, oral formulations for outpatients, and agents to combat rising drug resistance.
- Non-Traditional Approaches: Encouragingly, non-traditional biological agents, such as bacteriophages, antibodies, and microbiome-modulating agents, are being explored. However, these approaches face regulatory and clinical study challenges.
Since July 2017, 13 new antibiotics have been approved, but only 2 are considered innovative, highlighting the scientific and technical difficulties in discovering effective and safe novel antibacterials. Additionally, 3 non-traditional agents have been authorized, all faecal-based products for restoring gut microbiota to prevent recurrent Clostridioides difficile infection (CDI) in adults.
The preclinical pipeline remains active and innovative, focusing on Gram-negative pathogens, which are resistant to last-resort antibiotics and can transfer drug resistance to other bacteria. However, the shift towards single-pathogen targeting agents has plateaued, necessitating widely available and affordable rapid diagnostics to ensure effective treatment.
Greater transparency in the R&D pipeline could enhance collaboration, attract more interest and funding, and facilitate the development of novel antibacterial agents.
To effectively combat AMR, developing new antibacterial agents must be coupled with efforts to ensure equitable access, especially in low- and middle-income countries. Universal access to quality and affordable tools for preventing, diagnosing, and treating infections is essential to mitigating AMR’s public health and economic impacts, as outlined in WHO’s Strategic and Operational Priorities for Addressing AMR in the Human Health Sector, the AMR resolution adopted by the 77th World Health Assembly, and the People-centred approach to addressing AMR and core package of AMR interventions.
