https://www.cidrap.umn.edu/news-per...ecal-microbiota-product-recurrent-c-difficile
FDA approves fecal microbiota product for recurrent C difficile
Filed Under:
Antimicrobial Stewardship;
Clostridium difficile;
Fecal Transplant
Dec 01, 2022
The US Food and Drug Administration (FDA) announced yesterday that it has approved a fecal microbiota product for the prevention of recurrent Clostridioides difficile infection (CDI) in adults.
Approval of Rebyota, which was developed by Swiss biopharmaceutical company Ferring Pharmaceuticals, was based on analysis of multiple randomized clinical trials. The efficacy analysis found that the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%), while safety analysis found there were no serious treatment-related adverse events. The most common side effects after one dose of Rebyota were abdominal pain, diarrhea, abdominal bloating, gas, and nausea.
CDI—which occurs when C difficile bacteria multiply in the gut and release toxins, typically following antibiotic use—is a leading cause of hospital-acquired diarrhea and causes an estimated 500,000 and 29,000 deaths in the United States each year. Up to 35% of CDI cases recur after the initial episode, and patients who have recurrent infections have a significantly higher risk of further infection.
Prepared from stool donated by qualified individuals and delivered via enema, Rebyota is the first fecal microbiota product to be approved by the FDA. Fecal microbiota transplant therapy has been found in several studies to be an effective treatment for recurrent CDI compared with the standard of antibiotic therapy.
"Recurrent CDI impacts an individual's quality of life and can also potentially be life-threatening," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency press release. "As the first FDA-approved fecal microbiota product, today's action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI."
"We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs," Ferring President Per Falk, MD, PhD, said in a company press release.
Rebyota was approved for use in patients 18 years and older after they have completed antibiotic treatment for recurrent CDI.
FDA approves fecal microbiota product for recurrent C difficile
Filed Under:
Antimicrobial Stewardship;
Clostridium difficile;
Fecal Transplant
Dec 01, 2022
The US Food and Drug Administration (FDA) announced yesterday that it has approved a fecal microbiota product for the prevention of recurrent Clostridioides difficile infection (CDI) in adults.
Approval of Rebyota, which was developed by Swiss biopharmaceutical company Ferring Pharmaceuticals, was based on analysis of multiple randomized clinical trials. The efficacy analysis found that the overall estimated rate of success in preventing recurrent CDI through 8 weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%), while safety analysis found there were no serious treatment-related adverse events. The most common side effects after one dose of Rebyota were abdominal pain, diarrhea, abdominal bloating, gas, and nausea.
CDI—which occurs when C difficile bacteria multiply in the gut and release toxins, typically following antibiotic use—is a leading cause of hospital-acquired diarrhea and causes an estimated 500,000 and 29,000 deaths in the United States each year. Up to 35% of CDI cases recur after the initial episode, and patients who have recurrent infections have a significantly higher risk of further infection.
Prepared from stool donated by qualified individuals and delivered via enema, Rebyota is the first fecal microbiota product to be approved by the FDA. Fecal microbiota transplant therapy has been found in several studies to be an effective treatment for recurrent CDI compared with the standard of antibiotic therapy.
"Recurrent CDI impacts an individual's quality of life and can also potentially be life-threatening," Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research, said in an agency press release. "As the first FDA-approved fecal microbiota product, today's action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI."
"We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs," Ferring President Per Falk, MD, PhD, said in a company press release.
Rebyota was approved for use in patients 18 years and older after they have completed antibiotic treatment for recurrent CDI.