Not Enough Antibiotics in Drug Development – WHO’s Latest ‘Pipeline’ Report
electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown), a deadly bacteria resistant to many antibiotics, surrounded by cellular debris

The World Health Organization (WHO) has once more raised the red flag over the lack of new antibacterial treatments being developed to address the mounting threat of antimicrobial resistance (AMR).

In its annual  ‘pipeline report’, which assesses those antibacterial drugs in preclinical and clinical development, WHO describes the pipeline as “stagnant” and “far from meeting global needs.”

Since 2017 only 12 antibiotics have been approved, 10 of which belong to existing classes with established mechanisms of AMR. The 2021 report shows that only 27 new antibiotics are in clinical development against priority pathogens, four less than were being developed in 2017.

“This presents a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and leaves every one of us increasingly vulnerable to bacterial infections including the simplest infections,” said Dr Hanan Balkhy, WHO Assistant Director General on AMR.

Status of drugs in clinical trial development – WHO ‘Pipeline’ report 2021

The 2021 report, published in May and based on data from 2020, also highlights some of the barriers to drug development, foremost the lengthy pathway to approval, high cost and low success rates.

It takes 10 to 15 years to progress an antibiotic candidate from the preclinical and clinical stages and that only one in every 15 existing drugs in preclinical development and one in 30 for new classes reach patients.

“Time is running out to get ahead of antimicrobial resistance, the pace and success of innovation is far below what we need to secure the gains of modern medicine against age-old but devastating conditions like neonatal sepsis,” said Dr. Haileyesus Getahun, WHO Director of AMR Global Coordination.

Pipeline investment challenges and existing drug misuse

The Global Antimicrobial Research and Development Partnership (GARDP) has been created by WHO and the Drugs for Neglected Disease Initiative to accelerate the advancement of promising drug candidates in clinical trials.  However getting new drug candidates through costly Phase 2 and 3 trials remains challenging – with financial rewards insufficient for private industry even if a drug candidate succeeds.

The other problem is drug misuse and fake drug use. Worldwide, some 73% of antibiotics sold every year are used in animal health. That pattern, along with overprescription, misuse and use of weakened formulations in human medical settings all are increasing the prevalence of ‘superbugs’ and thus antimicrobial resistance (AMR) to some of the most common drug formulations.

AMR trends are most pronounced in low- and middle income countries of Asia and Latin America where regulations on both veterinary and human use of such drug are weak – with huge financial incentives to veterinarians who recklessly prescribe antibiotics to animals, and many antibiotics commonly available over-the-counter for human patients who then may use them to treat illnesses for which they are not effective. See related story:

Breeding Superbugs – Veterinary Drugs, More than Human Ones, Drive AMR 


Image Credits: NIAID, WHO .

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