Differences in Patient Access to Newly Approved Antibacterial Drugs in EU/EEA Countries.

ABSTRACT: The introduction of antibiotics in the beginning of the 20th century was one of the most important scientific breakthroughs in history. However, in recent decades, the growing threat of antimicrobial resistance (AMR) has shown the limitations of the current research and development programs for new antimicrobial drugs. In the last decade, 20 antibiotics, 7 β-lactam/β-lactamase inhibitor (BL/BLI) combinations and 4 non-traditional antibacterial drugs have been launched worldwide.

Methods

This study aimed to assess the time to patient access for new antibacterial drugs in countries in the European Union and the European Economic Area (EU/EEA). Time differences in marketing authorization from the U.S. Food and Drug Agency (FDA) and the European Medicines Agency (EMA) were also describe

SUBMITTER: Zasheva A 

PROVIDER: S-EPMC11591277 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature