Target product profiles for new antibacterial agents: severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis
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World Health Organization
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viii, 29 p.
This World Health Organization (WHO) report presents target product profiles (TPPs) for new antibacterial agents for the treatment of severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis. The TPPs outline the desired characteristics of novel antibiotics, including intended use, target populations, pharmacokinetics, safety, efficacy, route of administration, stability, and considerations related to access and affordability, to support research and development (R&D) of products addressing the most urgent public health needs posed by antimicrobial resistance (AMR). Building on previous WHO antibacterial TPPs, the report aligns product development with the WHO bacterial priority pathogens list (BPPL) 2024 and evidence from global antibacterial pipeline analyses. It prioritizes syndromes with high morbidity and mortality, particularly in low- and middle-income countries, and highlights the importance of integrating equity, stewardship and regulatory considerations, as well as strengthening public–private partnerships to accelerate development and ensure equitable access to new antibiotics.
This World Health Organization (WHO) report presents target product profiles (TPPs) for new antibacterial agents for the treatment of severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis. The TPPs outline the desired characteristics of novel antibiotics, including intended use, target populations, pharmacokinetics, safety, efficacy, route of administration, stability, and considerations related to access and affordability, to support research and development (R&D) of products addressing the most urgent public health needs posed by antimicrobial resistance (AMR). Building on previous WHO antibacterial TPPs, the report aligns product development with the WHO bacterial priority pathogens list (BPPL) 2024 and evidence from global antibacterial pipeline analyses. It prioritizes syndromes with high morbidity and mortality, particularly in low- and middle-income countries, and highlights the importance of integrating equity, stewardship and regulatory considerations, as well as strengthening public–private partnerships to accelerate development and ensure equitable access to new antibiotics.
Keywords
Drug Development, Anti-Bacterial Agents, Drug Resistance, Bacterial, Gram-Negative Bacteria, Meningitis, Bacterial, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections, World Health Organization, Immunocompromised Host, Critical Illness, Drug Resistance, Multiple, Pharmacokinetics, Treatment Outcome, Drug Design, Research Support as Topic, Public Health, Health Priorities, Health Equity, Costs and Cost Analysis, Delivery of Health Care, Morbidity, Global Health, Developing Countries, therapeutic use, drug therapy, organization and administration