The U.S. has approved a fecal transplant to treat a severe intestinal infection, according to the U.S. Food and Drug Administration (FDA).
The drug Rebyota from Ferring Pharmaceuticals is a fecal suspension of donor stool, a laxative, and saline. It is administered once into the patient's rectum using an enema.
Rebyota will be administered to treat recurrent Clostridioides difficile infection, Stat writes. This infection, which disrupts the balance of healthy gut bacteria, is accompanied by severe diarrhea, fever, nausea and abdominal pain. Severe inflammation of the colon can be life-threatening - 15,000 to 30,000 patients die from it each year in the United States alone.
The drug has been in development for 10 years, according to recent studies, the use of Rebyota reduces the likelihood of recurrence of the disease by 30%.
So far, it is the world's second official approval for the clinical use of microbiota transplants to treat patients. The first was issued in Australia less than a month ago to treat infections caused by the bacteria Clostridioides difficile.