Chijioke Iremeka
The World Health Organisation has raised concern over global antimicrobial resistance, warning that it is getting worse and that the world is yet to develop new trailblazing products fast enough to combat the most dangerous and deadliest bacteria.
In a statement on its website, the WHO highlighted the lack of medical innovation coupled with subsequent product authorisation, which it noted, poses significant access challenges.
Although the number of antibacterial agents in the clinical pipeline increased from 80 in 2021 to 97 in 2023, the global health body insisted that there is a pressing need for new, innovative agents for serious infections and to replace those becoming ineffective due to widespread use.
According to the WHO Assistant Director-General for Antimicrobial Resistance ad interim, Dr Yukiko Nakatani, the innovation is badly lacking, yet antibacterial agents are simply not reaching the patients who desperately need them in countries of all income levels.
He noted that AMR occurs when bacteria, viruses, fungi, and parasites no longer respond to medicines, making people sicker and increasing the risk of infection spread that are difficult to treat, illnesses, and deaths.
Nakatani added that AMR 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.
According to the WHO, there are insufficient antibacterials in the pipeline, considering the lengthy research and development timelines and the high likelihood of failure, compounded by inadequate innovation.
The WHO highlighted that out of 32 antibiotics in development for BPPL infections, only 12 are deemed innovative, with just four of these effective against at least one WHO ‘critical’ pathogen—a category representing the highest risk, above ‘high’ and ‘medium’ priorities.
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.
The statement reads in part, “Encouragingly, non-traditional biological agents, such as bacteriophages, antibodies, anti-virulence agents, immune-modulating agents, and microbiome-modulating agents, are increasingly being explored as complements and alternatives to antibiotics.
“However, studying and regulating non-traditional agents is not straightforward. Further efforts are needed to facilitate clinical studies and assessments of these products, to help determine when and how to use these agents clinically.
“Looking at newly approved antibacterials, since July 1, 2017, 13 new antibiotics have obtained marketing authorisation but only two represent a new chemical class and can be termed innovative, underscoring the scientific and technical challenge in discovering novel antibacterials that are both effective against bacteria and safe for humans.
“In addition, three non-traditional agents have been authorised, all are faecal-based products for restoring the gut microbiota, to prevent recurrent Clostridioides difficile infection following antibiotic treatment in adults.”
The global health body stated that the preclinical pipeline is active and innovative, incorporating many non-traditional approaches, and has maintained a stable number of preclinical candidates over the past four years.
Its focus, it noted, remains on Gram-negative pathogens, which are resistant to last-resort antibiotics. The organization emphasized that Gram-negative bacteria have built-in abilities to find new ways to resist treatment and can transfer genetic material that enables other bacteria to become drug-resistant as well.
The WHO stressed that the shift towards antibacterial agents targeting a single pathogen appears to have plateaued. It further noted that such agents increase the need for widely available and affordable rapid diagnostics to ensure the relevant bacteria are present in the infections to be treated.
“Greater transparency in the pipeline would: facilitate collaboration around potentially innovative but challenging projects, help scientists and drug developers, and generate more interest and funding for drug development for novel antibacterial agents.
“Efforts to develop new antibacterial agents need to be accompanied by parallel efforts to ensure they can be equitably accessed, particularly in low- and middle-income countries.
“Universal access to quality and affordable tools for preventing, diagnosing and treating infections is key to mitigating AMR’s impact on public health and the economy, as per 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 and core package of AMR interventions,” the WHO added.
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