Issue: January 2023
Fact checked byHeather Biele

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December 01, 2022
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FDA approves fecal microbiota biotherapeutic for recurrent C. difficile infection

Issue: January 2023
Fact checked byHeather Biele
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The FDA has approved Rebyota, a microbiota-based live biotherapeutic indicated for the prevention of recurrent Clostridioides difficile infection in adults after antibiotic treatment, Ferring Pharmaceuticals announced in a press release.

Perspective from Brian B. Baggott, MD, FACG

The approval comes after an FDA panel voted in favor of Rebyota (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.

Approved stamp
“This is the first FDA approval of a live biotherapeutic and the culmination of decades of research and clinical development,” Per Falk, president of Ferring Pharmaceuticals, said.
Source: Adobe Stock
Paul Feuerstadt, MD
Paul Feuerstadt

“When considering the management of C. difficile infection, 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 of C. difficile infection (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 of CDI diarrhea 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 recurrent C. difficile infection, 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.”

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