FDA approves Ferring’s first-in-class microbiota-based live biotherapeutic
pharmafile | December 1, 2022 | News story | Medical Communications |
Switzerland-based Ferring Pharmaceuticals announced the FDA has approved its biotherapeutic REBYOTA®, indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in patients over the age of eighteen, following antibiotic treatment.
REBYOTA® (fecal microbiota, live jslm) is a novel first-in-class microbiota-based live biotherapeutic. The FDA approved it after reviewing the results of the phase 3 PUNCH™ CD3 trial.
The randomised, double-blind, placebo-controlled trial showed REBYOTA® demonstrated superiority to the placebo as a treatment to reduce the recurrence of CDI after standard-of-care antibiotic treatment. 262 patients were enrolled, with the primary endpoint being treatment success ‒ the absence of diarrhoea within eight weeks of completing the study treatment.
Model-estimated treatment success at eight weeks was 70.6% for REBYOTA®, versus 57.5% for placebo, with a 99.1% posterior probability that REBYOTA® was superior to placebo in reducing recurrence of CDI after standard-of-care antibiotic treatment.
Side effects were recorded as mild-to-moderate, with no treatment-related serious adverse events (SAEs).
Per Falk, President, Ferring Pharmaceuticals stated: “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.”
“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, M.D., F.A.C.G., A.G.A.F., at Yale University School of Medicine.
James Spargo
