According to the FDA, in the United States, Clostridioides difficile is associated with 15,000 to 30,000 deaths per year.
According to a CDC study, 1 in 3 C. difficile infections were found to occur in patients 65 years of age or older.
The US health regulator, the Food and Drug Administration (FDA), on Wednesday approved the first fecal microbiota product to treat intestinal infection. The therapy is based on fecal transplants from Switzerland-based Ferring Pharmaceuticals to reduce the recurrence of a bacterial infection, making it the first therapy of its kind approved in the United States.
The FDA on Wednesday approved Rebyota for adults who have trouble fighting infections with Clostridium difficile, commonly known as C. diff, a bacterium that causes nausea, cramps and diarrhea.
According to the official statement from the FDA, the infection is particularly dangerous when it recurs and is linked to an estimated 15,000 to 30,000 deaths a year in the United States.
“Today’s approval of Rebyota is a breakthrough in the care of patients who have recurrent C. difficile infection,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Recurrent CDI affects an individual’s quality of life and can also 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 is administered via an enema and works by replenishing good gut bacteria through microbial samples distilled from the stool of healthy donors.
The efficacy of Rebyota was evaluated in an analysis of data from a multicentre, randomized, double-blind, placebo-controlled study. The analysis included 177 adults who received a dose of Rebyota and 85 who received a dose of placebo in this study.
It also incorporated success rates from another placebo-controlled study in which 39 adults received one dose of Rebyota and one dose of placebo and 43 adults received two doses of placebo. Success in preventing recurrent CDI was defined as the absence of CDI diarrhea within 8 weeks of Rebyota or placebo administration.
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