Approvals

CDI is caused by C. difficile, a bacterium that f lourishes in the human intestinal tract when the balance of natural microorganisms is affected, commonly by antibiotics. C. difficile releases toxins, which cause diarrhoea, abdominal pain, fever and, in serious cases, organ failure and death. After recovering from CDI, individuals may get the infection again multiple times, known as recurrent CDI.

Vowst is a faecal microbiota regimen containing live bacteria manufactured from donated faecal matter from healthy individuals. The treatment includes four capsules taken once daily for three consecutive days.

Vowst’s efficacy was evaluated in a randomised, double-blind, placebo-controlled, clinical study conducted in the US and Canada, which included 89 Vowst recipients and 93 placebo recipients 18 years of age and older with recurrent CDI. Through eight weeks of treatment, CDI recurrence in Vowst-treated participants was 12.4% compared to 39.8% in placebo-treated patients.

Peter Marks MD PhD, director of the FDA’s Center for Biologics Evaluation and Research, stated: “Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection. The availability of a faecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”