FDA Approves VOWST as a Treatment for Recurrent C. difficile Infection
The U.S. Food and Drug Administration (FDA) has given its approval to VOWST, a microbiota-based therapeutic that prevents the recurrence of C. difficile infection (CDI) in adults who have undergone antibacterial treatment for rCDI. Chief of Infectious Diseases at UC Davis Health, Stuart Cohen, conducted clinical trials that formed the basis for the FDA’s decision.
VOWST is the first and only microbiota-based therapeutic that can be orally administered for rCDI. Cohen remarked, “Recurrent C. difficile infection is a highly debilitating and life-threatening disease, and antibiotics alone do not address the underlying cause of rCDI. The approval of VOWST provides an important new oral treatment option for this disease and provides the opportunity to address prevention of recurrence of C. difficile infection in adults with rCDI.”
What is Recurrent C. difficile Infection?
rCDI is a gastrointestinal infection caused by C. difficile bacteria. It is associated with dysbiosis or an imbalance of the gastrointestinal microbiome, and it is one of the leading causes of hospital-acquired infections that can result in severe illness and death.
According to data from the U.S. Centers for Disease Control and Prevention (CDC), it is estimated that 156,000 episodes of rCDI will occur this year in the United States. The CDC recently classified the infection as an Urgent Health Threat.
Clinical Trials for VOWST
The FDA’s approval of VOWST was based on clinical data from Phase 3 trials called ECOSPOR III and ECOSPOR IV. The clinical trials were overseen by principal investigator Stuart Cohen, with Christine Gichigi serving as the clinical research coordinator.
ECOSPOR III was a randomized, placebo-controlled study that took place at over 50 healthcare sites in the United States and Canada. The clinical trial demonstrated that VOWST reduces C. difficile infection recurrence at eight weeks, with around 88% of individuals being recurrence-free at eight weeks post-treatment, compared to 60% of participants who received a placebo. At six months post-treatment, 79% of the VOWST group was recurrence-free, compared to 53% of the placebo group.
ECOSPOR IV was an open-label study, meaning that both providers and patients knew who was getting the treatment. Researchers evaluated VOWST in 263 adult participants with rCDI. Results showed that 91% of individuals were recurrence-free at eight weeks post-treatment, and at week 24 post-treatment, 86% were recurrence-free.
Conclusion
The FDA’s approval of VOWST provides an important new oral treatment option for adults with rCDI. With the increasing prevalence of this disease, VOWST offers an effective solution for preventing CDI recurrences and improving patients’ quality of life. Clinical trials have demonstrated the efficacy of VOWST, making it a promising treatment for rCDI.
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News Source : Liam Connolly
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