Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst's FDA approval and implications.
Nityanand JainTungki Pratama UmarAnne-Fleur FahnerValdis ĢībietisPublished in: Gut microbes (2023)
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.
Keyphrases
- drug administration
- clostridium difficile
- healthcare
- clinical trial
- end stage renal disease
- newly diagnosed
- randomized controlled trial
- ejection fraction
- chronic kidney disease
- emergency department
- drug delivery
- small molecule
- cell therapy
- prognostic factors
- peritoneal dialysis
- functional connectivity
- resting state
- drug induced
- risk assessment
- patient reported outcomes
- combination therapy
- clinical practice
- climate change
- bacillus subtilis
- phase ii
- current status
- smoking cessation
- open label
- electronic health record
- phase iii