Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications
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...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Gut Microbes |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/19490976.2023.2232137 |
| _version_ | 1797236674404548608 |
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| author | Nityanand Jain Tungki Pratama Umar Anne-Fleur Fahner Valdis Gibietis |
| author_facet | Nityanand Jain Tungki Pratama Umar Anne-Fleur Fahner Valdis Gibietis |
| author_sort | Nityanand Jain |
| collection | DOAJ |
| 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 reestablishing 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. |
| first_indexed | 2024-03-11T14:20:39Z |
| format | Article |
| id | doaj.art-af4e3a8427134f23a968cd1c670d72b7 |
| institution | Directory Open Access Journal |
| issn | 1949-0976 1949-0984 |
| language | English |
| last_indexed | 2024-04-24T17:07:36Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Gut Microbes |
| spelling | doaj.art-af4e3a8427134f23a968cd1c670d72b72024-03-28T22:38:19ZengTaylor & Francis GroupGut Microbes1949-09761949-09842023-12-0115110.1080/19490976.2023.2232137Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implicationsNityanand Jain0Tungki Pratama Umar1Anne-Fleur Fahner2Valdis Gibietis3Faculty of Medicine, Riga Stradinš University, Riga, LatviaFaculty of Medicine, Sriwijaya University, Palembang, IndonesiaDepartment of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA, USADepartment of Internal Diseases, Riga Stradinš University, Riga, LatviaABSTRACTClostridioides 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 reestablishing 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.https://www.tandfonline.com/doi/10.1080/19490976.2023.2232137Clostridioides difficilefecal microbiota transplantrecurrentinfectionsgastroenterologypharmacovigilance |
| spellingShingle | Nityanand Jain Tungki Pratama Umar Anne-Fleur Fahner Valdis Gibietis Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications Gut Microbes Clostridioides difficile fecal microbiota transplant recurrent infections gastroenterology pharmacovigilance |
| title | Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications |
| title_full | Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications |
| title_fullStr | Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications |
| title_full_unstemmed | Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications |
| title_short | Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst’s FDA approval and implications |
| title_sort | advancing therapeutics for recurrent clostridioides difficile infections an overview of vowst s fda approval and implications |
| topic | Clostridioides difficile fecal microbiota transplant recurrent infections gastroenterology pharmacovigilance |
| url | https://www.tandfonline.com/doi/10.1080/19490976.2023.2232137 |
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