The U.S. Food and Drug Administration said it has granted approval for Ferring Pharmaceuticals Inc.’s fecal microbiota product Rebyota.
The approval is for the prevention of recurrence of Clostridioides difficile infection or CDI in individuals 18 years of age and older. Rebyota will be used after an individual has completed antibiotic treatment for recurrent CDI.
Rebyota is the first fecal microbiota product approved by the agency.
The approval was based on safety assessement of the application from two randomized, double-blind, placebo-controlled clinical studies and from open-label clinical studies conducted in the United States and in Canada.
Clostridioides difficile or C. difficile is a bacterium that can cause CDI, a potentially life-threatening disease resulting in diarrhea and significant inflammation of the colon.
The agency noted that the intestinal tract contains millions of microorganisms, often referred to as the “gut flora,” or “gut microbiome.” Certain situations may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death.
After recovering from CDI, individuals may get the infection again, mostly multiple times, a condition known as recurrent CDI. According to FDA, the administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.
Rebyota, prepared from stool donated by qualified individuals, is administered rectally as a single dose. The effectiveness of Rebyota was evaluated in an analysis of data from a randomized, double-blind, placebo-controlled, multicenter study.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “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.”
The application was granted Fast Track, Breakthrough Therapy and Orphan designations.
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