THURSDAY, Dec. 1, 2022 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the first fecal microbiota treatment, aimed at helping adults battling tough-to-treat Clostridioides difficile infections (CDIs).
"Today's approval of Rebyota is an advance in caring for patients who have recurrent C. difficile infection," Peter Marks, M.D., director of the FDA Center for Biologics Evaluation and Research, said in an agency news release. "Recurrent CDI impacts an individual's quality of life and can also potentially be life-threatening. 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."
Rebyota, from Ferring Pharmaceuticals, is prepared from human stool donated by qualified individuals. Donors are tested for a range of transmissible pathogens, though there is still the possibility of transmitting infections, the FDA noted. The treatment is administered rectally in one dose.
Two randomized, double-blind clinical studies and some open-label clinical studies were completed prior to the approval to assess safety, involving a total of 978 adults. In one study, the most common side effects among 180 Rebyota recipients compared with 87 placebo recipients were abdominal pain, diarrhea, abdominal bloating, gas, and nausea. Those patients had received one or more doses of Rebyota or a placebo 24 to 72 hours after completing antibiotic treatment and their CDI was under control, the FDA said.
The FDA evaluated the treatment's effectiveness by analyzing data from a randomized, double-blind, placebo-controlled, multicenter study. This study included 177 adults who received one dose of Rebyota and 85 who received one dose of placebo. The analysis also incorporated success rates from a different placebo-controlled study in which 39 adults received one dose of Rebyota and one dose of placebo, and another 43 adults received two doses of placebo. Taking results from both studies, the overall success rate in preventing recurrent CDI for eight weeks was 70.6 percent in the Rebyota group and 57.5 percent in the placebo group.
Approval of Rebyota was granted to Ferring Pharmaceuticals.