Current and Future Initiatives to Incentivise the Development of Novel Antimicrobials

Tackling the rising problem of antimicrobial resistance

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This week, GSK announced that the pivotal phase III EAGLE-2 and EAGLE-3 trials evaluating gepotidacin, an investigational treatment for uncomplicated urinary tract infection, will stop early as they have already demonstrated efficacy and no safety concerns have been identified. This is exciting news, representing the potential first new oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years.

Gepotidacin was developed by GSK in partnership with the US government’s Biomedical Advanced Research and Development Authority (BARDA). BARDA is highly influential in global efforts to address AMR through its Broad Spectrum Antimicrobials programme and its contribution to the funding of CARB-X, an initiative designed to fund and support the early development of antibiotics, vaccines, and rapid diagnostics.

Gepotidacin is a clear example of the power of ‘push incentives’ to subsidise and incentivise the development of novel antibiotics, supporting the current and future R&D pipeline to meet demand and provide alternative treatments for drug-resistant infections.

Therefore, the news from GSK this week represents a huge step forward. However, the noise around gepotidacin also highlights the comparative silence in the rest of the field, and recent news in the UK has been disheartening. With reports of plans to allow pharmacists to prescribe antibiotics without a prescription under the ‘Plan for Patients’, and the recent debate sparked by news of the former health secretary sharing an antibiotic prescription with a friend, it is clear that the rising issue of AMR is not being prioritised in public policy.

In a recent interview, Dame Sally Davies the former chief medical officer for England, said she would like to see governments pushed to take action, whether on the surveillance of resistance, access to drugs or in ensuring new, and better, diagnostics and treatment.

The increasing widespread use and misuse of antimicrobials is driving the growing problem of antimicrobial resistance that could lead to a major global health disaster. Stewardship programmes, education and more accurate diagnosis will help to preserve the effectiveness of current drugs. However, the current antimicrobial pipeline is unlikely to prove sufficient against this growing problem of drug-resistant infections. Strategic and sustainable initiatives are required to encourage investment in the development of new, novel antimicrobials around the world.

In this comprehensive report, featuring the perspective of an industry organisation that has launched an antimicrobial therapy, Nancy Cross, Consultant at Lightning Health, reviews the current and future initiatives to incentivise the development of novel antimicrobials and outlines what is required to ensure sustainable change to avoid a global health disaster.



Article published 9 November 2022