Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.
Full prescribing information for Rebyota is available online.
Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.