On Wednesday, the Food and Drug Administration (FDA) approved Rebyota. This is the first fecal microbiota product ever to be approved by the regulator. It was used to prevent the recurrence of Clostridioides difficile Infection (CDI) in people 18 years and older and can be administered after a patient has completed antibiotic treatment for recurrent CDI.
Clostridium difficileor C. diff, is a bacterium that causes cramps, nausea and diarrhea. It can be especially dangerous when it recurs and is linked to about 15,000 to 30,000 deaths a year. People over 65 are at increased risk of developing CDI, but other risk factors include hospitalization, a compromised immune system, and a history of CDI. Some patients may get the infection again after recovery, and the risk of further recurrence increases with each infection. Treatment options for recurrent CDIs are limited, according to the FDA.
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“Today’s approval of Rebyota is a step forward in the care of patients with relapses C. difficile infection,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Recurrent CDI impacts a person’s quality of life and can also potentially be life-threatening. As the first fecal microbiota product approved by the FDA, today’s action represents an important milestone as it provides an additional approved option to prevent recurrent CDI.”
Millions of microorganisms, often referred to as the intestinal flora or intestinal microbiome, live in the intestinal tract. Some situations, such as taking antibiotics to treat an infection, can change the balance of microorganisms in the gut. This can enable C. diff To multiply and release toxins that cause diarrhea, abdominal pain, fever, and in some cases organ failure and death.
For more than 10 years, some physicians in the United States have used stool samples from healthy donors to treat CDI. The healthy bacteria in a sample from a donor’s gut can help transplant recipients fight C. diff Bacteria. Because many patients do not respond to conventional antibiotics, this procedure is becoming more common.
However, the growing number of fecal transplant practitioners and chair banks in the US has created regulatory confusion for the FDA, which traditionally does not regulate medical procedures performed by physicians. As long as stool donors are carefully screened for potential infectious diseases, the FDA has rarely intervened in the use of this process.
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The approved treatment is given as a single dose through the rectum. It is made from stool donated by qualified individuals, all of whom have been tested for a range of transmissible pathogens. The FDA emphasizes that because Rebyota is made from human feces, it still carries the risk of transmitting infectious agents and may contain food allergens. The potential of the product to cause allergic reactions to food is currently unknown. The addition of fecal microbiota is believed to restore gut flora to prevent further episodes of CDI.
The safety of Rebyota was evaluated in two randomized, double-blind, placebo-controlled clinical studies and in open-label clinical studies conducted in the United States and Canada. In the studies, symptoms had cleared in 70 percent of patients taking Rebyota after eight weeks, compared with 58 percent of those taking placebo.
The new therapy is manufactured by Swiss company Ferring Pharmaceuticals Inc. at a facility in Minnesota.