US approves Rebyota for severe intestinal infection informs US Federal Food and Drug Administration on the official website.
Rebyota is a fecal suspension of donated feces, laxatives, and saline. It is injected once into the patient’s rectum by enema. Thus, transplantation of fecal microbiota occurs to treat infections caused by Clostridioides difficile bacteria. Signs of infection include severe diarrhea, fever, nausea and abdominal pain. Also, severe inflammation can cause death.
The drug has been under development for 10 years, according to recent studies, the use of Rebyota reduces the likelihood of recurrence of the disease by 30%. Currently, this is the second official worldwide approval for the clinical use of microbiota transplantation for the treatment of patients. The drug was first approved in Australia about a month ago.