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

ABSTRACT

Clostridioides 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.

KEYWORDS:

• Clostridioides difficile
• fecal microbiota transplant
• recurrent
• infections
• gastroenterology
• pharmacovigilance
• oral FMT
• Vowst

Disclosure statement

No potential conflict of interest was reported by the author(s).

Author’s contribution

NJ conceptualized the present paper whilst NJ, TPU, and AFF were involved in data collection, data validation, and preparation of the initial draft of the manuscript. NJ, TPU, AFF, and VG were responsible for revising the manuscript. Supervision and project administration was done by VG. All authors have read and agreed to the final version of the paper for publication.

Data availability statement

Not applicable. No new data was generated for this paper.

Additional information

Funding

The present paper did not receive any external funding and was self-supported by the authors.