Ferring Pharmaceuticals gets Rebyota FDA approval for recurring CDI
Rebyota FDA approval : Ferring Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Rebyota (fecal microbiota, live-jslm), a microbiota-based live biotherapeutic, for the prevention of recurrence of Clostridioides difficile infection (CDI).
Rebyota, a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration, is indicated for use in individuals 18 years of age and older, after antibiotic treatment for recurrent infection of the large intestine.
Rebyota FDA approval is driven by the findings of PUNCH CD3, a randomized, double-blind, placebo-controlled phase 3 trial in which a single dose of the microbiota-based live biotherapeutic reduced recurrence of CDI after standard-of-care antibiotic treatment.
Brent Ragans — Ferring Pharmaceuticals U.S. President, commenting on Rebyota FDA approval, said: “Rebyota is a much-needed new treatment that offers hope to the thousands of people who suffer from recurrent C. difficile infection each year.
“Rebyota has the potential to impact not only patients and caregivers, but also the healthcare system.”
During the PUNCH CD3 clinical trial, 262 participants received blinded treatment, of which 177 were on Rebyota and the remaining 85 on placebo. The estimated treatment success rate at eight weeks for Rebyota was 70.6% compared to 57.5% for the placebo arm.
Per Falk — Ferring Pharmaceuticals President 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.”
Sourced from qualified donors and tested for a panel of transmissible pathogens, Rebyota is not indicated for the first occurrence of Clostridioides difficile infection.