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.