TY - JOUR
T1 - The infectious diseases society of America's 10 × '20 initiative (10 new systemic antibacterial agents US food and drug administration approved by 2020)
T2 - Is 20 × '20 a possibility?
AU - Infectious Diseases Society of America
AU - Talbot, George H.
AU - Jezek, Amanda
AU - Murray, Barbara E.
AU - Jones, Ronald N.
AU - Ebright, Richard H.
AU - Nau, Gerard J.
AU - Rodvold, Keith A.
AU - Newland, Jason G.
AU - Boucher, Helen W.
N1 - Funding Information:
Financial support. The Infectious Diseases Society of America (IDSA) received no financial support from outside sources for its policy work and preparation of this report.
Funding Information:
Potential conflicts of interest. G. H. T., through Talbot Advisors LLC, has received board compensation and/or consultancy fees from Actelion, Arsanis, Nabriva Therapeutics (board of directors), and Zavante and also has contingent equity interests in AN2 Therapeutics, Calixa, Nabriva, Recida and Tripex. A. J. is an employee of IDSA. R. N. J. is a consultant at JMI Laboratories, which was contracted to perform services in 2016–2017 for Achaogen, Allecra Therapeutics, Allergan, Amplyx Pharmaceuticals, Antabio, API, Astellas Pharma, AstraZeneca, Athelas, Basilea Pharmaceutica, Bayer AG, BD, Becton, Dickinson and Co., Boston, CEM-102 Pharma, Cempra, Cidara Therapeutics, Inc., CorMedix, CSA Biotech, Cutanea Life Sciences, Inc., Entasis Therapeutics, Inc., Geom Therapeutics, Inc., GSK, Iterum Pharma, Medpace, Melinta Therapeutics, Inc., Merck & Co., Inc., MicuRx Pharmaceuticals, Inc., N8 Medical, Inc., Nabriva Therapeutics, Inc., NAEJA-RGM, Novartis, Paratek Pharmaceuticals, Inc., Pfizer, Polyphor, Ra Pharma, Rempex, Riptide Bioscience Inc., Roche, Scynexis, Shionogi, Sinsa Labs Inc., Skyline Antiinfectives, Sonoran Biosciences, Spero Therapeutics, Symbiotica, Synlogic, Synthes Biomaterials, TenNor Therapeutics, Tetraphase, The Medicines Company, Theravance Biopharma, VenatoRx Pharmaceuticals, Inc., Wockhardt, Yukon Pharma, Zai Laboratory, and Zavante Therapeutics, Inc. B. E. M. has served as a consultant to or on an advisory board for Cempra and Paratek, is a co-investigator on grants to the University of Texas from Actavis and Merck, has received royalties for chapters she wrote for UpToDate, and has received honoraria and/or travel reimbursement for lectures and grand rounds from nonpharmaceutical organizations. R. H. E. has received funding from the National Institutes of Health (NIH) and has patent filings on antibiotics. G. J. N. has received funding from the NIH and has patents on antimicrobial compounds for which there has been no remuneration. K. A. R. has served as a consultant to or on an advisory board for Accelerate Diagnostics, Achaogen, Bayer, BLC-TAZ, Entasis, GSK, Medicine Company/Melinta, Meiji, Merck, Motif, Nabriva, Paratek, Shionogi, Spero Therapeutics, Tetraphase, Theravance, Wockhardt, Zavante and has received research grant funding from Theravance and Allergan. J. G. N. has received grant funding from Merck. H. W. B. has served as a consultant for Cardeas (data monitoring committee). All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© The Author(s) 2018.
PY - 2019/6/18
Y1 - 2019/6/18
N2 - Background. Infections caused by antibiotic-resistant bacteria, including carbapenem-resistant Enterobacteriaceae, have increased in frequency, resulting in significant patient morbidity and mortality. The Infectious Diseases Society of America continues to propose legislative, regulatory, and funding solutions to address this escalating crisis. This report updates the status of development and approval of systemic antibiotics in the United States as of late 2018. Methods. We performed a review of the published literature and on-line clinical trials registry at www.clinicaltrials.gov to identify new systemically acting orally and/or intravenously administered antibiotic drug candidates in the development pipeline, as well as agents approved by the US Food and Drug Administration since 2012. Results. Since our 2013 pipeline status report, the number of new antibiotics annually approved for marketing in the United States has reversed its previous decline, likely influenced by new financial incentives and increased regulatory flexibility. Although our survey demonstrates progress in development of new antibacterial drugs that target infections caused by resistant bacterial pathogens, the majority of recently approved agents have been modifications of existing chemical classes of antibiotics, rather than new chemical classes. Furthermore, larger pharmaceutical companies continue to abandon the field, and smaller companies face financial difficulties as a consequence. Conclusions. Unfortunately, if 20 × '20 is achieved due to efforts embarked upon in decades past, it could mark the apex of antibiotic drug development for years to come. Without increased regulatory, governmental, industry, and scientific support and collaboration, durable solutions to the clinical, regulatory, and economic problems posed by bacterial multidrug resistance will not be found.
AB - Background. Infections caused by antibiotic-resistant bacteria, including carbapenem-resistant Enterobacteriaceae, have increased in frequency, resulting in significant patient morbidity and mortality. The Infectious Diseases Society of America continues to propose legislative, regulatory, and funding solutions to address this escalating crisis. This report updates the status of development and approval of systemic antibiotics in the United States as of late 2018. Methods. We performed a review of the published literature and on-line clinical trials registry at www.clinicaltrials.gov to identify new systemically acting orally and/or intravenously administered antibiotic drug candidates in the development pipeline, as well as agents approved by the US Food and Drug Administration since 2012. Results. Since our 2013 pipeline status report, the number of new antibiotics annually approved for marketing in the United States has reversed its previous decline, likely influenced by new financial incentives and increased regulatory flexibility. Although our survey demonstrates progress in development of new antibacterial drugs that target infections caused by resistant bacterial pathogens, the majority of recently approved agents have been modifications of existing chemical classes of antibiotics, rather than new chemical classes. Furthermore, larger pharmaceutical companies continue to abandon the field, and smaller companies face financial difficulties as a consequence. Conclusions. Unfortunately, if 20 × '20 is achieved due to efforts embarked upon in decades past, it could mark the apex of antibiotic drug development for years to come. Without increased regulatory, governmental, industry, and scientific support and collaboration, durable solutions to the clinical, regulatory, and economic problems posed by bacterial multidrug resistance will not be found.
KW - Antibiotic pipeline
KW - Antimicrobials
KW - Gram-negative bacilli
UR - http://www.scopus.com/inward/record.url?scp=85067462207&partnerID=8YFLogxK
U2 - 10.1093/cid/ciz089
DO - 10.1093/cid/ciz089
M3 - Review article
C2 - 30715222
AN - SCOPUS:85067462207
SN - 1058-4838
VL - 69
SP - 1
EP - 11
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 1
ER -