The approval is based on the findings from a clinical programme including data from the late-stage PUNCH CD3 trial in which REBYOTA reduced the recurrence of CDI
US FDA approves Ferring’s Rebyota for the treatment of recurring Clostridioides difficile infection. (Credit: Ficcc/Wikimedia Commons
The US Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ Rebyota (faecal microbiota, live-jslm) for the prevention of recurrence of Clostridioides difficile infection (CDI) in people aged 18 years and above.
According to the Switzerland-based biopharmaceutical firm, the microbiota-based live biotherapeutic has been indicated to be used after antibiotic treatment for recurrent CDI.
The FDA approval is based on the data from the clinical programme that includes the randomised, double-blind, placebo-controlled PUNCH CD3 phase 3 trial.
Ferring Pharmaceuticals said that 262 trial participants received blinded treatment and the primary endpoint of the experiment was the success of the treatment, which was determined as the absence of CDI diarrhoea within eight weeks of finishing the study therapy.
The results showed that REBYOTA outperformed placebo when used as a treatment to lessen CDI recurrence following standard-of-care antibiotic treatment, the biopharmaceutical firm added.
The Switzerland-based firm claimed that the Bayesian model’s estimated treatment success rate for REBYOTA after eight weeks was 70.6% against 57.5% for placebo. This was with a 99.1% posterior probability that the faecal microbiota candidate was superior to placebo in lessening recurrent CDI.
More than 90% of participants in the trial who had treatment success had no recurrence of CDI through six months, the firm concluded.
Ferring Pharmaceuticals president Per Falk said: “We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs.
“This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development.
“Today’s announcement is not just a milestone for people living with recurrent C. difficile infection, but also represents a significant step which holds promise that many other diseases might be better understood, diagnosed, prevented and treated using our rapidly evolving insights on the role of the microbiome in human health and disease.”
The pre-packaged REBYOTA is said to be a single-dose 150 mL microbiota suspension for rectal administration. It is sourced from qualified donors and tested for different transmissible pathogens.