Challenges in anti-infective development in the era of bad bugs, no drugs: a regulatory perspective using the example of bloodstream infection as an indication.
Bloodstream infections present many challenges to clinicians. The number of hospitalized patients with bloodstream infection continues to increase, and the number of newly available antimicrobial agents to treat these particularly lethal infections and many other serious infections continues to decrease. Drug-development programs for bloodstream infection that have adhered to existing regulatory guidelines have not been significantly successful. This article examines the regulatory history of the bloodstream infection indication as an example of the challenges faced by individuals and sponsors developing drugs for treatment of the current spectrum of antimicrobial-resistant infections, with the goal of providing insight into development pathways for agents targeting drug-resistant bacterial pathogens. Disease-specific and pathogen-specific indications are discussed, and recent regulatory approvals for bloodstream infection caused by vancomycin-resistant Enterococcus faecium and methicillin-resistant Staphylococcus aureus are reviewed.
Boucher
Helen W
HW
Division of Infectious Diseases, Tufts University Medical School and Tufts Medical Center, Boston, Massachusetts 02111, USA. hboucher@tuftsmedicalcenter.org
D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D016470:Bacteremia / Q000188:drug therapy* / Q000382:microbiology; D017277:Drug Approval; D015195:Drug Design; D004348:Drug Labeling; D016984:Enterococcus faecium / Q000187:drug effects*; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy / Q000382:microbiology; D006801:Humans; D055624:Methicillin-Resistant Staphylococcus aureus / Q000187:drug effects*; D014481:United States; D014486:United States Food and Drug Administration; D020713:Vancomycin Resistance
D000900:Anti-Bacterial Agents