On April 22, a significant step was taken in the medical world – the European Commission gave their approval to Emblaveo, a new antibiotic presented by Pfizer, aimed at combating the ever-growing threat of antibiotic resistance. This menace has quickly escalated to become one of the most severe health challenges currently faced by the European Union.
Emblaveo will be designated for the treatment of complicated intra-abdominal and urinary tract infections, as well as hospital-acquired pneumonia. Importantly, the new antibiotic has been developed with an eye on combating infections arising from specific types of drug-resistant bacteria.
As stated in an EU executive press release, “This newly approved medicine will fill an important gap where there are currently a very limited number of treatment options.” This approval comes as a direct consequence of a positive review and recommendation from the European Medicines Agency (EMA) that occurred a month earlier. Application of EMA’s accelerated assessment mechanism was considered necessary due to the significant public health benefits that the antibiotic may provide.
The dangers posed by antimicrobial resistance are far-reaching and severe, often referred to as a ‘silent pandemic’. Statistics compiled by the World Health Organisation (WHO) have indicated that antimicrobial resistance is intricately linked with approximately 4.9 million deaths every year, with the EU recording responsibility for 35,000 of these deaths.
This resistance has been engendered by the misuse and over prescription of antibiotics, causing microorganisms, known colloquially as ‘superbugs’, to adapt and develop resistance. This resistance ultimately renders medications less effective, allowing infections to persist and, worryingly, escalating the risk of further spread.
The combat against antimicrobial resistance (AMR) has been a high-priority target for health policy during the most recent mandate. A recommendation was issued by the European Council in 2023 which advocated for the intensification of EU action against antimicrobial resistance across the spheres of human health, animal health and the environment.
The EU has adopted a ‘One Health’ strategy, acknowledging the interconnectedness of human and animal health with the environment. Tackling AMR effectively necessitates a coordinated attack on all these fronts. As part of this commitment, one of the Council’s recommendations outlined specific targets to decrease antimicrobial consumption and resistance in human health, featuring a 20% reduction in total human consumption of antibiotics by the year 2030.
A range of measures have been put forward to bolster surveillance across all levels, including hospitals and long-term care facilities, in an attempt to strengthen infection prevention and control. The fight against AMR also formed an integral aspect of the pharmaceutical legislation review. One of the proposals from the European Commission was a system of transferable data exclusivity vouchers to encourage the formulation of new antibiotics. This scheme would endow developers with an added year of regulatory data protection which could be utilized for their products or sold to another marketing authorization holder.
Source: https://www.euronews.com/health/2024/04/22/commission-approves-superbug-busting-antibiotic