The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18 years of age and older after an antibiotic treatment for recurrent CDI.
The novel, first-in-class, microbiota-based live biotherapeutic comes in a pre-packaged, single-dose, 150 mL microbiota suspension for rectal administration. Rebyota is sourced from qualified donors and tested for a panel of transmissible pathogens.
“Until now, patients living with the devastating cycle of recurrent C. difficile infection have had limited FDA-approved treatment options, causing them to suffer long periods of time with debilitating symptoms that prevent them from leaving their homes and even separate them from immediate family members,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine, in a press release.
The FDA granted approval to Rebyota based on findings from a clinical program that included results from the randomized, double-blind, placebo-controlled, phase 3 PUNCH CD3 trial. The data show that a single dose of Rebyota demonstrated superiority compared with placebo in decreasing the recurrence of CDI following standard-of-care antibiotic treatment.
In the trial, 262 participants were administered blinded treatment (n=177, Rebyota; n=85, placebo) with a primary endpoint of treatment success defined as the absence of CDI diarrhea within 8 weeks following completion of the study treatment.
The Bayesian model-estimated treatment success rate at 8 weeks for Rebyota was 70.6% compared with 57.5% for placebo. The study showed a 99.1% posterior probability that Rebyota was superior to placebo in reducing recurrent CDI following standard-of-care antibiotic treatment. Additionally, more than 90% of participants who achieved treatment success remained free of CDI recurrence through 6 months.