Read nextFDA approves fecal microbiota biotherapeutic for recurrentC. difficileinfection
Click Here to Manage Email Alerts
美国食品和药物管理局已批准Rebyota microbiota-based live biotherapeutic indicated for the prevention of recurrentClostridioides difficileinfection in adults after antibiotic treatment, Ferring Pharmaceuticals announced in a press release.
The approval comes after an FDA panel voted in favor ofRebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals)in September 2022, with the Vaccines and Related Biological Products Advisory Committee voting 13-4 in favor of the availability of adequate data supporting effectiveness and 12-4, with one abstention, in favor of the availability of adequate data supporting safety.
“When considering the management ofC. difficileinfection, the better part of the last decade has been spent chasing the dream of a codified form of microbiota restoration therapy that both patients and providers can expect predictable effectiveness and safety,”Paul Feuerstadt, MD, FACG, AGAF,of Yale University School of Medicine, told Healio.“That day has come, and I could not be more delighted for our medical community.”
According to the release, the FDA approval is based on results from the randomized, double-blind, placebo-controlled phase 3 PUNCH CD3 trial, which demonstrated that a single dose of Rebyota was superior to placebo in reducing recurrence ofC. difficileinfection(CDI) after standard-of-care antibiotic treatment. The trial included 262 patients, of whom 177 received Rebyota and 85 received placebo.
Treatment success, defined as the absence ofCDIdiarrhea within 8 weeks after treatment completion, was reported in 70.6% of patients receiving Rebyota compared with 57.5% in the placebo group, the release stated. More than 90% of patients who achieved treatment success were CDI recurrence-free through 6 months.
According to Ferring, study-reported adverse events related to Rebyota were mild to moderate in severity and included gastrointestinal symptoms. There were no serious treatment-emergent adverse events.
“We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs,”Per Falk,president of Ferring Pharmaceuticals, said in the release. “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 recurrentC. difficileinfection, 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.”
Reference:
- FDA panel votes in favor of fecal transplant therapy for recurrentC. difficileinfection.//www.johnmartes.com/news/gastroenterology/20220928/fda-panel-votes-in-favor-of-fecal-transplant-therapy-for-recurrent-c-difficile-infection. Published Sept. 28, 2022. Accessed Dec. 1, 2022.
Perspective
Back to Top
We are entering an exciting period of restorative microbiome therapeutics. Of the nearly 500,000 patients who developClostridioides difficileinfection (CDI) every year in the United States, 25% will enter a cycle of recurrent disease with each recurrence increasing the risk for another. This can have a huge impact on a patient’s life.
Recurrent CDI is thought to occur because antibiotics successfully treat the current CDI but do not treatC. difficilespores, which leads to further infection when the antibiotics are stopped. Over the past decade, fecal microbiota transplantation (FMT) has been shown in many controlled studies to be effective in breaking the cycle of recurrent CDI. It appears to act by restoring the gut microbiota, which has been shown to inhibit spore germination.
With the FDA approval of Rebyota, we have the first commercially available FMT product that has passed rigorous FDA requirements for phase 1, 2 and 3 trials.
Read more about
Click Here to Manage Email Alerts