Advancing therapeutics for recurrent clostridioides difficile Infections : an overview of vowst's FDA approval and implications

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dc.contributor.authorJain, Nityanand
dc.contributor.authorUmar, Tungki Pratama
dc.contributor.authorFahner, Anne Fleur
dc.contributor.authorĢībietis, Valdis
dc.contributor.institutionFaculty of Medicine
dc.contributor.institutionDepartment of Internal Diseases
dc.date.accessioned2023-07-25T10:55:01Z
dc.date.available2023-07-25T10:55:01Z
dc.date.issued2023-07-11
dc.descriptionFunding Information: The present paper did not receive any external funding and was self-supported by the authors. Publisher Copyright: © 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.
dc.description.abstractClostridioides difficile infections (CDI) are a leading cause of healthcare-associated infections with a high relapse rate. Current treatment guidelines recommend fidaxomicin as the primary therapy for initial CDI episodes and suggest alternative approaches for recurrent episodes, including fecal microbiota transplantation (FMT). This paper explores the recent approval of Vowst, a novel oral FMT drug, by the United States Food and Drug Administration (FDA) as a prophylactic therapy to prevent recurrent CDIs. Vowst comprises a formulation of live fecal microbiota spores and works by re-establishing the disrupted gut microbiota, limiting C. difficile spore germination, and promoting microbiome repair. Furthermore, this paper will discuss the product’s approval journey and the uncertainties regarding its efficacy in CDI patients beyond the ones who participated in the clinical trials, pharmacovigilance, cost estimates, and the need for a more stringent donor screening process. Overall, Vowst’s approval marks a significant step forward in the prevention of recurrent CDI infections with various beneficial implications for future gastroenterology.en
dc.description.statusPeer reviewed
dc.format.extent10
dc.format.extent338274
dc.identifier.citationJain, N, Umar, T P, Fahner, A F & Ģībietis, V 2023, 'Advancing therapeutics for recurrent clostridioides difficile Infections : an overview of vowst's FDA approval and implications', Gut Microbes, vol. 15, no. 1, 2232137. https://doi.org/10.1080/19490976.2023.2232137
dc.identifier.doi10.1080/19490976.2023.2232137
dc.identifier.issn1949-0976
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/14171
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85164299561&partnerID=8YFLogxK
dc.identifier.urlhttps://www.tandfonline.com/doi/full/10.1080/19490976.2023.2232137
dc.language.isoeng
dc.relation.ispartofGut Microbes
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectClostridium difficile
dc.subjectoral
dc.subjectFecal microbiota transplantation
dc.subjectrecurrent
dc.subjectinfections
dc.subjectgastroenterology
dc.subjectpharmacovigilance
dc.subjectVowst
dc.subjectSER-109
dc.subjectfecal microbiota
dc.subject3.1 Basic medicine
dc.subject3.4 Medical biotechnology
dc.subject3.3 Health sciences
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectGeneral Immunology and Microbiology
dc.subjectGeneral Medicine
dc.subjectPharmacology, Toxicology and Pharmaceutics(all)
dc.subjectSDG 3 - Good Health and Well-being
dc.titleAdvancing therapeutics for recurrent clostridioides difficile Infections : an overview of vowst's FDA approval and implicationsen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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