The European Medicines Agency Approved the New Antibacterial Drugs – Response to the 2017 Who Report on the Global Problem of Multi-Drug Resistance

Abstract

Abstract The growing problem of antimicrobial resistance has been classified by the World Health Organization (WHO) as one of the top ten threats to mankind. In a special report published in 2017, the WHO presented a list of microorganisms for which the search for new therapeutic options is a priority. The highest (critical) priority was given to the search for new antibiotics active against carbapenem-resistant strains of Acinetobacter baumannii and Pseudomonas aeruginosa as well as against carbapenem- and third-generation-cephalosporin-resistant Enterobacterales strains (so-called critical priority pathogens). Whereas the second (high) priority was given among others to the search for new antibiotics active against methicillin- and vancomycin-resistant strains of Staphylococcus aureus (MRSA and VRSA) and vancomycin-resistant strains of Enterococcus faecium (VRE). Since the publication of the WHO report the European Medicines Agency has approved 6 novel, broad-spectrum antibiotics, from 6 different groups, addressing the priority pathogens to a different extent. Two of them are new combinations of carbapenems with non-β-lactam inhibitors of β-lactamases (active also against carbapenemases), belonging to two novel groups of inhibitors: diazabicyclooctanes (relebactam, combined with imipenem) and boronates (vaborbactam, combined with meropenem). The third new drug is a siderophore cephalosporin (cefiderocol) with an innovative mechanism of penetration into the bacterial cell. The next two antibiotics are the new fluoroquinolone (delafloxacin) and the new tetracycline (eravacycline), designed and synthesized to be more active than older members of these groups. The last innovative antibiotic is lefamulin – the first pleuromutilin approved for systemic use in humans. New approvals have expanded the number of available therapeutic options in the treatment of complicated urinary tract infections (meropenem/vaborbactam, cefiderocol), complicated intra-abdominal infections (meropenem/vaborbactam, eravacycline), nosocomial pneumonia (meropenem/vaborbactam, imipenem/relebactam), acute bacterial skin and skin structure infections (delafloxacin) and community-acquired pneumonia (lefamulin).