TGA approves new antibiotic but AMR blind spot remains a critical concern

The Therapeutic Goods Administration (TGA) has approved a new antibiotic for the treatment of carbapenem-resistant Gram-negative bacterial infections. Developed by Japanese pharma Shionogi, Cefiderocol is distributed by Link Medical Products in Australia.

The approval comes as antimicrobial resistance (AMR), often described as a ‘silent pandemic’, continues to emerge as one of the most significant global public health threats. With resistant infections becoming increasingly difficult to treat and therapeutic options remaining limited, AMR represents an urgent global challenge and an area of significant unmet medical need.

The regulatory decision for Cefiderocol is supported by data from three global clinical trials: the Phase 2 APEKS-cUTI study, the Phase 3 CREDIBLE-CR study and the Phase 3 APEKS-NP study. Based on these findings, the TGA has approved cefiderocol for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, as well as hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

The introduction of a new treatment comes against a backdrop of mounting concern over the scale and drivers of antimicrobial resistance. More than 50% of the world’s antibiotics are still being used in livestock, with Australia ranking among the top five countries in antimicrobial use in animals.

The consequences extend well beyond veterinary medicine. AMR in livestock poses a direct threat to human health, with resistant pathogens capable of crossing from animals to people through the consumption of meat, milk and eggs. Australia, China, Brazil, India and the USA collectively account for 58% of global antimicrobial use in livestock, with tetracyclines the most widely used class.

The economic implications are also substantial. Hospitalisations associated with these infections already cost Australia an estimated $700 million each year. Without new interventions, the overall economic burden could reach between $142 billion and $283 billion by 2050.

Experts argue that Australia needs radical policy solutions to stimulate the development and availability of new antibiotics. One proposed approach is the Subscription Model, which was endorsed in the Health Technology Assessment (HTA) Review. Under the model, healthcare systems pay a fixed amount at regular intervals for access to new antibiotics, creating a more predictable commercial incentive for developers and potentially helping to revive a stalled global pipeline for novel antimicrobials.

The UK has already adopted such an approach, with its subscription programme making new antibiotics available to patients, including Pfizer’s Zavicefta (ceftazidime/avibactam). Australia, by comparison, provides clinicians with far fewer options. Of the 25 novel antimicrobials launched in the US and Europe since 2011, less than five are registered in Australia.

The country has, however, played a historic role in antibiotic development. Nearly a century ago, Australian scientist Howard Florey helped transform Alexander Fleming’s discovery of penicillin into the world’s first mass-produced antibiotic, a breakthrough that fundamentally altered the course of modern medicine.

Today, the CSIRO warns that “…history calls on us to do something equally ambitious: not to chase evermore powerful ‘superdrugs’ for ‘superbugs,’ but to pull out all the stops to preserve the ones we still have.”

Preserving the effectiveness of existing antibiotics, while ensuring access to new treatments when they are needed, will require action well beyond pharmaceutical innovation. Strengthening antibiotic stewardship in human medicine must be matched by changes in livestock practices, given the interconnected nature of antimicrobial use, resistance and transmission.

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