Literature DB >> 27905086

Bezlotoxumab: First Global Approval.

Anthony Markham1.   

Abstract

Bezlotoxumab (Zinplava™) is a human monoclonal antibody against Clostridium difficile toxin B developed by Merck & Co. In October 2016 it was approved in the USA for reducing the recurrence of C. difficile infection. This article summarizes the milestones in the development of bezlotoxumab leading to this first approval for use in patients receiving antibacterial drug treatment for C. difficile infection who are at high risk for recurrence of C. difficile infection.

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Year:  2016        PMID： 27905086     DOI： 10.1007/s40265-016-0673-1

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  6 in total

1.  Human monoclonal antibodies against Clostridium difficile toxins A and B inhibit inflammatory and histologic responses to the toxins in human colon and peripheral blood monocytes.

Authors:  Hon Wai Koon; David Q Shih; Tressia C Hing; Jun Hwan Yoo; Samantha Ho; Xinhua Chen; Ciarán P Kelly; Stephan R Targan; Charalabos Pothoulakis
Journal:  Antimicrob Agents Chemother       Date:  2013-04-29       Impact factor: 5.191

2.  Broad coverage of genetically diverse strains of Clostridium difficile by actoxumab and bezlotoxumab predicted by in vitro neutralization and epitope modeling.

Authors:  Lorraine D Hernandez; Fred Racine; Li Xiao; Edward DiNunzio; Nichelle Hairston; Payal R Sheth; Nicholas J Murgolo; Alex G Therien
Journal:  Antimicrob Agents Chemother       Date:  2014-12-01       Impact factor: 5.191

3.  Disease Progression and Resolution in Rodent Models of Clostridium difficile Infection and Impact of Antitoxin Antibodies and Vancomycin.

Authors:  Peter Warn; Pia Thommes; Abdul Sattar; David Corbett; Amy Flattery; Zuo Zhang; Todd Black; Lorraine D Hernandez; Alex G Therien
Journal:  Antimicrob Agents Chemother       Date:  2016-10-21       Impact factor: 5.191

4.  Mechanisms of protection against Clostridium difficile infection by the monoclonal antitoxin antibodies actoxumab and bezlotoxumab.

Authors:  Zhiyong Yang; Jeremy Ramsey; Therwa Hamza; Yongrong Zhang; Shan Li; Harris G Yfantis; Dong Lee; Lorraine D Hernandez; Wolfgang Seghezzi; Jamie M Furneisen; Nicole M Davis; Alex G Therien; Hanping Feng
Journal:  Infect Immun       Date:  2014-12-08       Impact factor: 3.441

5.  Treatment with monoclonal antibodies against Clostridium difficile toxins.

Authors:  Israel Lowy; Deborah C Molrine; Brett A Leav; Barbra M Blair; Roger Baxter; Dale N Gerding; Geoffrey Nichol; William D Thomas; Mark Leney; Susan Sloan; Catherine A Hay; Donna M Ambrosino
Journal:  N Engl J Med       Date:  2010-01-21       Impact factor: 91.245

6.  Mechanism of action and epitopes of Clostridium difficile toxin B-neutralizing antibody bezlotoxumab revealed by X-ray crystallography.

Authors:  Peter Orth; Li Xiao; Lorraine D Hernandez; Paul Reichert; Payal R Sheth; Maribel Beaumont; Xiaoyu Yang; Nicholas Murgolo; Grigori Ermakov; Edward DiNunzio; Fred Racine; Jerzy Karczewski; Susan Secore; Richard N Ingram; Todd Mayhood; Corey Strickland; Alex G Therien
Journal:  J Biol Chem       Date:  2014-05-12       Impact factor: 5.157
  6 in total
  8 in total

1.  AAV-mediated delivery of actoxumab and bezlotoxumab results in serum and mucosal antibody concentrations that provide protection from C. difficile toxin challenge.

Authors:  Matthew M Guilleman; Brenna A Y Stevens; Laura P Van Lieshout; Amira D Rghei; Yanlong Pei; Lisa A Santry; Brad Thompson; Sarah K Wootton
Journal:  Gene Ther       Date:  2021-02-19       Impact factor: 5.250

2.  A probiotic yeast-based immunotherapy against Clostridioides difficile infection.

Authors:  Kevin Chen; Yixuan Zhu; Yongrong Zhang; Therwa Hamza; Hua Yu; Ashley Saint Fleur; James Galen; Zhiyong Yang; Hanping Feng
Journal:  Sci Transl Med       Date:  2020-10-28       Impact factor: 17.956

Review 3.  Application of Antibody-Mediated Therapy for Treatment and Prevention of Clostridium difficile Infection.

Authors:  Beatrix Förster; Pui Khi Chung; Monique J T Crobach; Ed J Kuijper
Journal:  Front Microbiol       Date:  2018-06-25       Impact factor: 5.640

Review 4.  Clostridioides difficile Infection in Patients after Organ Transplantation-A Narrative Overview.

Authors:  Sylwia Dudzicz-Gojowy; Andrzej Więcek; Marcin Adamczak
Journal:  J Clin Med       Date:  2022-07-27       Impact factor: 4.964

5.  Clostridioides difficile TcdB Toxin Glucosylates Rho GTPase by an SNi Mechanism and Ion Pair Transition State.

Authors:  Ashleigh S Paparella; Sean M Cahill; Briana L Aboulache; Vern L Schramm
Journal:  ACS Chem Biol       Date:  2022-08-29       Impact factor: 4.634

Review 6.  Comparison of Different Strategies for Providing Fecal Microbiota Transplantation to Treat Patients with Recurrent Clostridium difficile Infection in Two English Hospitals: A Review.

Authors:  Simon D Goldenberg; Rahul Batra; Ian Beales; Jonathan Leith Digby-Bell; Peter Miles Irving; Lee Kellingray; Arjan Narbad; Ngozi Franslem-Elumogo
Journal:  Infect Dis Ther       Date:  2018-02-15

7.  Recommendations for the diagnosis and treatment of Clostridioides difficile infection: An official clinical practice guideline of the Spanish Society of Chemotherapy (SEQ), Spanish Society of Internal Medicine (SEMI) and the working group of Postoperative Infection of the Spanish Society of Anesthesia and Reanimation (SEDAR).

Authors:  E Bouza; J M Aguado; L Alcalá; B Almirante; P Alonso-Fernández; M Borges; J Cobo; J Guardiola; J P Horcajada; E Maseda; J Mensa; N Merchante; P Muñoz; J L Pérez Sáenz; M Pujol; E Reigadas; M Salavert; J Barberán
Journal:  Rev Esp Quimioter       Date:  2020-02-20       Impact factor: 1.553

8.  Inhibition of Clostridium difficile TcdA and TcdB toxins with transition state analogues.

Authors:  Ashleigh S Paparella; Briana L Aboulache; Rajesh K Harijan; Kathryn S Potts; Peter C Tyler; Vern L Schramm
Journal:  Nat Commun       Date:  2021-11-01       Impact factor: 14.919
  8 in total

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