The for Ferring Pharmaceuticals鈥� faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above.
A live biotherapeutic, Rebyota is intended for usage following the completion of antibiotic treatment.
Rebyota鈥檚 safety and efficacy were analysed in the largest trial programme in the microbiome-based therapeutics field, including five trials enrolling over 1,000 subjects.
The latest development is based on the findings from the clinical programme including the double-blind, randomised, placebo-controlled Phase III PUNCH CD3 trial.
According to data from the PUNCH CD3 trial, a single dose of Rebyota showed to be superior versus placebo for lowering CDI recurrence following standard-of-care antibiotic treatment.
Over 90% of subjects in the Rebyota arm, who had treatment success, were found to be CDI recurrence-free for six months.
US Tariffs are shifting - will you react or anticipate?
Don鈥檛 let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataAdditionally, mild-to-moderate adverse events (AEs) were reported in the trial without any serious adverse events (SAEs) linked to the treatment observed.
Indicated for administration rectally, Rebyota is a single-dose 150ml microbiota suspension.聽
Made from stool donated by eligible people, the therapy is also tested for various transmissible pathogens.
Ferring Pharmaceuticals president Per Falk said: 鈥淭his is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development.
鈥淭he announcement is not just a milestone for people living with recurrent C. difficile infection, but also represents a significant step which holds a 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.鈥�
