George H Talbot1, Amanda Jezek2, Barbara E Murray3, Ronald N Jones4, Richard H Ebright5, Gerard J Nau6, Keith A Rodvold7, Jason G Newland8, Helen W Boucher9. 1. Talbot Advisors LLC, Anna Maria, Florida. 2. Infectious Diseases Society of America, Arlington, Virginia. 3. Division of Infectious Diseases, McGovern Medical School at the University of Texas Health Science Center, Houston. 4. JMI Laboratories, North Liberty, Iowa. 5. Department of Chemistry and Waksman Institute, Rutgers University, Piscataway, New Jersey. 6. Division of Infectious Diseases, Alpert Medical School at Brown University, Providence, Rhode Island. 7. College of Pharmacy, University of Illinois at Chicago. 8. Division of Pediatric Infectious Diseases, Washington University, St. Louis, Missouri. 9. Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts.
Abstract
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.
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.
Authors: Patricia J Simner; Stephan Beisken; Yehudit Bergman; Michael Ante; Andreas E Posch; Pranita D Tamma Journal: Microb Drug Resist Date: 2021-10-06 Impact factor: 3.431
Authors: Jeffrey R Strich; Emily Ricotta; Sarah Warner; Yi Ling Lai; Cumhur Y Demirkale; Samuel F Hohmann; Chanu Rhee; Michael Klompas; Tara Palmore; John H Powers; John P Dekker; Jennifer Adjemian; Roland Matsouaka; Christopher W Woods; Robert L Danner; Sameer S Kadri Journal: Clin Infect Dis Date: 2021-02-16 Impact factor: 9.079