WHO warns of urgent need for innovative antibiotics despite pipeline growth

In an era where medical advancements are celebrated daily, a silent crisis looms large, threatening to unravel decades of progress in global health.

According to the latest World Health Organisation (WHO) report on antibacterial agents, including antibiotics, in clinical and preclinical development worldwide, antimicrobial resistance (AMR) stands as one of the most formidable challenges, a relentless force that renders most potent medicines ineffective against evolving pathogens.

AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to medicines, making people sicker and increasing the risk of spread of infections that are difficult to treat, illness and deaths.

It is driven largely by the misuse and overuse of antimicrobials, yet, at the same time, many people around the world do not have access to essential antimicrobial medicines.

“Antimicrobial resistance is only getting worse yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly bacteria,” said Dr Yukiko Nakatani, WHO’s Assistant Director-General.

“Innovation is badly lacking yet, even when new products are authorized, access is a serious challenge. Antibacterial agents are simply not reaching the patients who desperately need them in countries of all income levels."

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Not only are there too few antibacterials in the pipeline, given how long is needed for R&D and the likelihood of failure, there is also not enough innovation. Of the 32 antibiotics under development to address BPPL infections, only 12 can be considered innovative.

Furthermore, just 4 of these 12 are active against at least 1 WHO ‘critical’ pathogen – critical being the BPPL’s top risk category, over ‘high’ and ‘medium’ priority.

There are gaps across the entire pipeline, including in products for children, oral formulations more convenient for outpatients, and agents to tackle rising drug resistance.

While the number of antibacterial agents in the clinical pipeline has increased from 80 in 2021 to 97 in 2023, the WHO emphasizes a pressing need for new, innovative agents to combat serious infections and replace those becoming ineffective due to widespread use.

The organisation has also unveiled its updated Bacterial Priority Pathogens List (BPPL) for 2024, highlighting the ongoing global threat of antibiotic-resistant bacteria. The list, which guides research and development (R&D) efforts for new antibiotics, has undergone significant changes since its initial release in 2017.

Since July 2017, 13 new antibiotics have obtained marketing authorization, but only two represent a new chemical class and can be termed innovative. Additionally, three non-traditional agents have been authorized, all fecal-based products for preventing recurrent Clostridioides difficile infection in adults following antibiotic treatment.

The preclinical pipeline remains active and innovative, with many non-traditional approaches focusing on Gram-negative pathogens resistant to last-resort antibiotics. These bacteria have built-in abilities to find new ways to resist treatment and can pass along genetic material for drug resistance to other bacteria.

WHO calls for greater transparency in the pipeline to facilitate collaboration, help scientists and drug developers, and generate more interest and funding for novel antibacterial agent development.

This aligns with 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-centered approach to addressing AMR with core interventions.