DISCOVERIES (ISSN 2359-7232), 2019, October-December issue
Submitted: December 29th, 2019; Revised: December 31st, 2019; Accepted: December 31st, 2019; Published online: December 31st, 2019;
GO BACK to 2019, October-December issue
GO BACK to DISCOVERIES
FDA approved antibacterial drugs: 2018-2019
Stefan Andrei (1,2,3,*), Gabriela Droc (1,2), Gabriel Stefan (2,4)
(1) Department of Anesthesia and Intensive Care, Fundeni Clinical Institute, Bucharest, Romania
(2) Carol Davila University of Medicine and Pharmacy, Bucharest, Romania
(3) Université Paris Sud XI, Faculté de Médecine, Le Kremlin-Bicêtre, France
(4) Dr. Davila Teaching Hospital of Nephrology, Bucharest, Romania
*Corresponding author: Stefan Andrei, MD, Department of Anesthesia and Intensive Care, Fundeni Clinical Institute, 258 Soseaua Fundeni, Bucharest, 022328, Romania; Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; Université Paris Sud XI, Faculté de Médecine, 63 Rue Gabriel Péri, 94270 Le Kremlin-Bicêtre, France; stefan.m.andrei@gmail.com
Abstract
Bacterial resistance to existent antibiotherapy is a perpetual internationally-recognized problem. Year after year, there is a continuous need for novel antibacterial drugs and this research and development efforts recently resulted in few new drugs or combination of drugs proposed for the use into the clinic.
This review focuses on the novel US FDA approved antibacterial agents in the last two years (2018-2019). Plazomicin, eravacycline, sarecycline, omadacycline, rifamycin (2018) and imipenem, cilastatin and relebactam combination, pretomanid, lefamulin, cefiderocol (2019) are new therapeutic options. Plazomicin aminoglycoside antibiotic targets Enterobacteriaceae infections, being mainly used for the complicated urinary tract infections. The fully synthetic fluorocycline eravacycline gained approval for the complicated intra-abdominal infections. The tetracycline-derived antibiotic sarecycline might be a useful strategy for the management of non-nodular moderate to severe acne, while the other tetracycline-derived antibiotic approved, omadacycline, may be used for the patients with acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. The already-known RNA-synthesis suppressor rifamycin is now also approved for noninvasive Escherichia Coli-caused travelers' diarrhea. Two combinatorial strategies were approved for complicated urinary tract infections, complicated intra-abdominal infections (imipenem, cilastatin and relebactam) and lung tuberculosis (pretomanid in combination with bedaquiline and linezolid). Lefamulin is a semisynthetic pleuromutilin antibiotic for community-acquired bacterial pneumonia, while cefiderocol, a cephalosporin antibiotic is the last antibacterial drug approved in 2019, for the use in complicated urinary tract infections.
Despite of these new developments, there is an ongoing need and urgency to develop novel antibiotic strategies and drugs to overrun the bacterial resistance to antibiotics.
Access full text of the manuscript here: Full text (pdf)
References
1. Droz N. et al. Bacterial pathogens and resistance causing community acquired paediatric bloodstream infections in low- and middle- income countries: a systematic review and meta-analysis. Antimicrobial Resistance and Infection Control. 2019;5:1–12.2. Kopotsa K. et al.Plasmid evolution in carbapenemase-producing Enterobacteriaceae : a review. Ann. N.Y. Acad. Sci. 2019;1–31.
3. Seykere J.O. et al. Molecular Epidemiology, Diagnostics and Mechanisms of Antibiotic Resistance in Mycobacterium tuberculosis complex in Africa: A Systematic Review of Current Reports. J Infect. 2019;
4. Bretonnière C. et al. Strategies to reduce curative antibiotic therapy in intensive care units (adult and paediatric). Intensive Care Med. 2015;41(7):1181–96.
5. Derde L.P.G. et al. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: An interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014;14(1):31–9.
6. Gabriel S. et al. Catheter-related infections in chronic hemodialysis: a clinical and economic perspective. 2013;817–23.
7. Campion M. et al. Antibiotic Use in the Intensive Care Unit: Optimization and De-Escalation. Journal of Intensive Care Medicine. 2018 Dec;33(12):647-655.
8. Bassetti M. et al. Preventive and therapeutic strategies in critically ill patients with highly resistant bacteria. Intensive Care Med. 2015;41(5):776–95.
9. Vounba P. et al. Prevalence of colistin resistance and mcr-1 / mcr-2 genes in extended-spectrum β -lactamase / AmpC-producing Escherichia coli isolated from chickens in Canada, Senegal and Vietnam. J Glob Antimicrob Resist. 2019;19:222–7.
10. Liu Y. et al. Emergence of plasmid-mediated colistin resistance mechanism MCR-1 in animals and human beings in China: a microbiological and molecular biological study. Lancet Infect Dis. 16(2):161–8.
11. Ramakrishnan B. et al. Local applications but global implications: Can pesticides drive microorganisms to develop antimicrobial resistance? Sci Total Environ. 2019;654:177–89.
12. Das K.R. et al. Co-selection of multi-antibiotic resistance in bacterial pathogens in metal and microplastic contaminated environments: an emerging health threat. Chemosphere. 2018.
13. Mularoni A. et al. Epidemiology and successful containment of a carbapenem ‐ resistant Enterobacteriaceae outbreak in a Southern Italian Transplant Institute. Transpl Infect Dis. 2019;(May):1–8.
14. Gyssens I.C. Role of education in antimicrobial stewardship. Med Clin N Am. 2018;102:855–71.
15. Lewalter S.W.L.K. Antibiotic stewardship and horizontal infection control are more effective than screening, isolation and eradication. Infection 2018;46(5):735–6.
16. Bassetti M. et al. Treatment of Infections Due to MDR Gram-Negative Bacteria. 2019;6(April):1–10.
17. Andrei S. et al. New FDA approved antibacterial drugs: 2015-2017. Discoveries 2018; 6(1):2015–7. doi:10.15190/d.2018.1.
18. Hussar D.A. New Drugs 2019 Part 4. Nursing 2019. 2019;49(11).
19. Zemdri (plazomicin) FDA Highlights of Prescribing Information [cited 2019 Dec 10]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210303Orig1s000lbl.pdf
20. Eljaaly K. et al. Plazomicin : A Novel Aminoglycoside for the Treatment of Resistant Gram ‑ Negative Bacterial Infections. Drugs. 2019.
21. Wagenlehner F.M.E. et al. Once-Daily Plazomicin for Complicated Urinary Tract Infections. N Engl J Med. 2019;729–40.
22. Scott L.J. Eravacycline : A Review in Complicated Intra ‑ Abdominal Infections. Drugs. 2019;79(3):315–24.
23. Tetraphase Pharmaceuticals Inc. Xerava (Eravacycline): US prescribing information. 2018. [cited 2018 Oct 21]. Available from: https://www.accessdata. fda.gov/drugsatfda_docs/label/2018/211109lbl.pdf
24. European Medicines Agency. Xerava (Eravacycline): summary of product characteristics. 2018. [cited 2018 Nov 1]. Available from: https://www.ema.europa.eu /en/documents/product-information/xerava-epar-product-information_en.pdf
25. Solomkin J. et al., Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial. JAMA Surgery. 2016;45243.
26. Solomkin J. et al. IGNITE4: Results of a Phase 3 , Randomized , Multicenter , Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. 2019;69:921–9.
27. Kaul G. et al. Sarecycline hydrochloride for the treatment of acne vulgaris. Drugs Today (Barc). 2019;Oct;55(10):615–25.
28. Moore A. et al. Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. J Drugs Dermatol. 2018; Sep 1;17(9):987–96.
29. Moore A.Y. et al. Sarecycline : a narrow spectrum tetracycline for the treatment of moderate-to-severe acne vulgaris. 2019; 14:1235–42.
30. Zodvold K.A. Omadacycline : A Review of the Clinical Pharmacokinetics and Pharmacodynamics. Clin Pharmacokinet 2019;(Iv).
31. Opal S. et al. An Integrated Safety Summary of Omadacycline , a Novel Aminomethylcycline Antibiotic. Clinical Infectious Diseases Supplement. 2019;69(Suppl 1):40–7.
32. Lan S. et al. The efficacy and safety of omadacycline in treatment of acute bacterial infection. Medicine. 2019;51(November).
33. CosmoPharmaceuticals press release. [cited 2019 Feb 4]. Available from: https://www.cosmopharma.com/news-and-media/press-releases-and-company-news/2018/ 181119
34. Hoy SM. Rifamycin SV M MX®: A Review in the Treatment of Traveller’s Diarrhoea. Clin Drug Investig. 2019;39(7):691–7.
35. Steffen, R. et al. Rifamycin SV-MMX for treatment of travellers’ diarrhea: equally effective as ciprofloxacin and not associated with the acquisition of multi-drug resistant bacteria. Journal of Travel Medicine. 2018;1–11.
36. CenterWatch [cited 2019 Oct 10]. Available from: https://www.centerwatch.com/directories/1067-fda-approved-drugs/listing/4098-recarbrio-imipenem-cilastatin-and-relebactam
37. Merck Press Release 2019 [cited 2019 Sep 18]. Available from: https://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-recarbrio-imipenem-cilastatin-and-releba
38. Recarbrio (imipenem, cilastatin, and relebactam) FDA highlights of prescribing information [cited 2019 Nov 28]. Available from: https://www.accessdata.fda.gov/ drugsatfda_docs/label/2019/212819s000lbl.pdf
39. Pretomanid FDA highlights of prescribing information [cited 2019 Dec 16]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212862Orig1s000Lbl.pdf
40. Rxlist [cited 2019 Nov 10]. Available from: https://www.rxlist.com/pretomanid-side-effects-drug-center.htm
41. Tweed C.D. et al. Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre , open-label, partially randomised , phase 2b trial. Lancet Respir 2019;7(12):1048–58.
42. Krishnan V. Tuberculosis: experts question evidence and safety. BMJ. 2019;6832(December):2–3.
43. Lefamulin (Xenleta) for Community-Acquired Bacterial Pneumonia. Med Lett Drug Ther. 2019;61.
44. File T.M. et al. Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial. 2019;69(Iv).
45. Alexander E. et al. Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia The LEAP 2 Randomized Clinical Trial. 2019;19406.
46. Choi J.J.& McCarthy, M.W. Cefiderocol : A novel siderophore cephalosporin Ac Expert Opin Investig Drugs. 2018;0(0).
47. Sato T. & Yamawaki, K. Cefiderocol: Discovery, Chemistry, and In Vivo Profiles of a Novel Siderophore Cephalosporin. Clinical Infectious Diseases. 2019; 69(Suppl 7).
48. Ito A. et al. In Vitro Antibacterial Properties of Cefiderocol, a Novel Cephalosporin, against Gram-Negative Bacteria. Antimicrob Agents Chemother. 2018; 62:01454-17.
49. Zhanel G.G. et al. Cefiderocol: A Siderophore Cephalosporin with Activity Against Carbapenem ‑ Resistant and Multidrug ‑ Resistant Gram ‑ Negative Bacilli. Drugs 2019 Feb;79(3):271-289.
50. Interagency Coordination Group on Antimicrobial Resistance. No time to wait: securing the future from drug-resistant infections – report to the Secretary-general of the United Nations. 2019 April. Available from: https://www.who.int/antimicrobial-resistance/interagency-coordination-group/final-report/en/
51. Pew Charitable Trusts. Antibiotics Currently in Global Development. 2019 September, [cited 2019 Oct 18]. Available from:
https://www.pewtrusts.org//media/assets/2019/08/arp_antibiotics_currently_in_global_clinical_development_data_table_v2.pdf?la=en&hash=F729686986DD0403BCF05F5E61F91AB545066B77
52. Riordan W.O. et al. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1. Clinical Infectious Diseases, 66 (8). pp. 1222-1229;
53. Noviello S. et al. Iclaprim: A differentiated option for the treatment of skin and skin structure infections. Expert Rev Anti Infect Ther. 2018;0(0):1.
54. Imai Y. et al. A new antibiotic selectively kills Gram- negative pathogens. Nature. 2019; 576(7787):459-464.
55. Luther A. et al. Chimeric peptidomimetic antibiotics against Gram-negative bacteria. Nature. 2019 Dec; 576 (7787):452-458.
56. Hart, E.M. et al.A small-molecule inhibitor of BamA impervious to efflux and the outer membrane permeability barrier. Proc Natl Acad Sci U S A. 2019 Oct 22;116(43):21748-2175.
57. Nicolas I. et al. Novel antibiotics effective against gram- positive and -negative multi-resistant bacteria with limited resistance. PLoS Biol. 2019;17(7).
58. McCurdy S. et al. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017;61(9).
59. Abbas M. et al. New and improved? A review of novel antibiotics for Gram-positive bacteria. Clin Microbiol Infect. 2017;23(10):697–703.
60. Tobudic S. et al. Dalbavancin as Primary and Sequential Treatment for Gram-Positive Infective Endocarditis: 2-Year Experience at the General Hospital of Vienna. Clinical Infectious Diseases. 2018;67:795–8.
61. Esposito S. et al. Dalbavancin for the treatment of acute bacterial skin and skin structure infections. Le Infezioni in Medicina. 2015;313–7.
News & Events Latest news from Discoveries
- 2022, April| AWARDS!
2022 Discoveries Award winning articles!
- Kinal Bhatt et al. 2021 (Larking Health System, FL, USA); Bhatt K, Agolli A, Patel MH, et al. High mortality co-infections of COVID-19 patients: mucormycosis and other fungal infections. Discoveries. 2021;9(1):e126.
27 citations in the past 1 year - $1000 prize- Hasnain Jan et al. 2020 (Quaid-i-Azam University, Pakistan); Jan H, Faisal S, Khan A, et al. COVID-19: Review of Epidemiology and Potential Treatments Against 2019 Novel Coronavirus. Discoveries. 2020;8(2):e108.
23 citations in the past 2 years - $400 prizeCongratulations! Prizes will be received by the awardees in July 2022!
- 2021, July| 2021, Jul-September
Due to the high volume of the submitted articles, both Discoveries and Discoveries Reports are experiencing processing and publication delays during the months of July-September 2021. We will get back to the normal processing and publication times starting in October 2021. Note that our editorial and administrativ work is fully funded by our publishing house at this time and we are striving to KEEP THE NO FEE/NO CHARGE strategy in place as long as possible.
- 2021, January| AWARDS!
2022 DISCOVERIES AWARDS! Discoveries will offer $1000 and $400 awards in early 2022, for the most cited (2021 ISI Citations) and visible articles published in 2018-2021.
- 2020, November| Follow us on Twitter!
You can now follow the latest Discoveries news and updates on Twitter! (@DiscoveriesNews)
- 2020, August| For Authors!
Due to a high volume of article submissions, our peer-review process takes more than usual. The pre-screening decision is released in 1-2 days, while the peer-review process lasts between 10 and 20 days.
- 2020, April | For Authors!
WE DO NOT TOLERATE ANY MISCONDUCT! Please be aware that we are testing all received articles with specialized software for PLAGIARISM and WE WILL TAKE MEASURES if your article is already published or in consideration for publication by other journals! This may result in serious professional consequences for the authors. The latest striking case is the following article which is already published and was re-submitted here.
- 2020, April | For Authors!
We are happy to let you know that all articles published in Discoveries are now included in PubMedCentral (PMC). New accepted articles will be included in PMC and PubMed within 1-2 weeks after their publication.
- 2020, January | For Authors!
Starting in January 2020, Discoveries will also consider articles submitted by Discoveries' Editorial Board members. However, only a small number of such articles (maximum 4 articles/year) will be considered for publication after the peer-review process, and the authors who are also our editors will be clearly disclosed on our website.
- 2019, September | Indexed by PMC
Discoveries is now indexed by PubMedCentral and Pubmed. The agreement with US National Library of Medicine was signed on September 10, 2019. Our next step is ISI Web of Science indexing. NOTE: previously published articles will be included on PubMed in early 2020.
- 2019, September | PubMed inclusion!
We are happy to let you know that Discoveries successfuly passed the last step (Technical Review) required for PubMedCentral and PubMed inclusion!
- 2019, July | PubMed inclusion News!
We are happy to receive positive comments from PMC/NLM-NIH regarding Discoveries' last step (Technical Review) required for PubMedCentral and PubMed inclusion. We will let you know once whole indexing process is completed.
- 2019| Sharing and Distribution!
All articles published in Discoveries are Open Access articles distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited and it is not used for commercial purposes.
- 2018-2019 | For Authors!
From now on and for at least 1 year, we will only accept articles from authors that are NOT members of Discoveries' Editorial Board. All articles submitted by our editors will be immediately rejected until further notice (one accepted article was already rejected).
- 2018 | PubMed inclusion News!
Discoveries successfully passed the Scientific Quality Review by NLM-NIH for PubMedCentral and PubMed indexing. This is the first and the most important step towards PubMedCentral and PubMed indexing! The second (last) step is the Technical Review.
- 2016, April | Faster Peer-Review
Starting on April 13th 2016, all articles selected for a peer-review will receive the post peer-review decision within ~10 days. The initial pre-screening time will remain the same (48h from the submission of the manuscript). This decision will significantly accelerate the publication, with no effect on the quality of the peer-review process.
- 2016, February | Manuscript submission
Discoveries is commited to excellence, quality and high editorial standards. We are receiving an increasing number of manuscripts for which the identity of the authors/corresponding author can't be verified. Please NOTE that ALL these articles were and will be immediately REJECTED. Indicating an institutional email address is the easiest way to overcome this problem! Moreover, we do not accept any pressure on our editorial board to accept a manuscript. This results in a prompt rejection of the article.
Editorial Policies - 2016, January | Main Objective
After reaching all proposed milestones until now (including being indexed by Google Scholar in 2014), Discoveries' next Aim is PubMed indexing of all its articles (already published and upcoming). There will be no charge for the submission or publication of articles before Discoveries is indexed.
- 2015, August | Discoveries - on PubMed
We are happy to announce that our first Discoveries articles were included in PMC and PubMed. More articles (submitted by NIH funded authors) are now processed for being included.
Discoveries articles now on PubMed - 2015, April | Special Issue
DISCOVERIES published the SPECIAL ISSUE entitled "INFLAMMATION BETWEEN DEFENSE AND DISEASE: Impact on Tissue Repair and Chronic Sickness".
Special Issue on "Inflammation" - 2015 | Ischemia Collection
DISCOVERIES launched a call for papers for a Collection of Articles with focus on "ISCHEMIA". If you are interested to submit a manuscript, please contact us at info@discoveriesjournals.org
- 2014, September | Special Issue
DISCOVERIES just publish the SPECIAL ISSUE entitled "CELL SECRETION & MEMBRANE FUSION" in September 2014. Initially scheduled for publication between October 2014-March 2015, this issue was successfully published earlier than scheduled.
Special Issue - 2014, April | Indexed by Google Scholar
All our published articles are now indexed by Google Scholar! First citations to Discoveries articles are included! Search for the article's title (recommended) or the authors:
Google Scholar Search - 2014 | DISCOVERIES
DOIs (Digital Object Identifiers) are now assigned to all our published manuscripts in Discoveries. DOI uniquely identifies an article and is provided by CrossRef.
CrossRef - 2013, July | Manuscript Submission
Submit your manuscript FREE, FAST and EASY ! (in less than 1 minute)! There are NO fees for the manuscript submission or publishing of the accepted manuscripts.
read more - 2013, July | DISCOVERIES
We are now ACCEPTING MANUSCRIPTS for publishing in DISCOVERIES. We aim publishing a small number of high impact experimental articles & reviews (around 40/year) to maintain a high impact factor. Domains of interest: all areas related to Medicine, Biology and Chemistry ...
read more