Europe to boost development of new antimicrobial drugs

Abstract

There are several reasons why development of new antimicrobial drugs has stalled in Europe (and in fact worldwide). Among them is the diffi culty to develop antibiotics targeting pathogens endowed with antimicrobial resistance. In addition, the regulatory environment within Europe is such that new drugs need to show non-inferiority in clinical trials within a margin of 10% as compared with current gold standards; this is quite challenging since many participants in a clinical trial may not be infected with the bacteria being targeted by the new drug. As these drugs are taken for limited courses not for life, this also restricts possible profi tability. These factors have coalesced to make development of new antimicrobials a largely unattractive prospect for drug companies. Antibiotic-resistant infections kill around 25 000 patients in Europe each year and represent a global cost in the European Union (EU) of around €1·5 billion (US$1·85 billion) per year. Yet as the pipeline for new antimicrobials has slowed to a crawl, so have levels of resistance to existing drugs increased. The problem of antimicrobial resistance is particularly acute for Gram-negative bacteria. In addition, meticillin-resistant Staphylococcus aureus (MRSA) remains a major threat worldwide as a hospitalacquired pathogen. Fortunately, the rates of MRSA are decreasing in hospitals in some EU Member States, as shown by the latest data from European Centre for Disease Control. But in the USA, community-acquired MRSA poses a substantial threat. Cases of community-acquired MRSA in Europe could also increase substantially in the near future. Add to this the recent emergence of the New Delhi metallo-β-lactamase (NDM-1) enzyme, which can make many common Gramnegative bacteria resistant to all known antibiotics, and the necessity for rapid action to develop new drugs becomes startlingly clear.