02 December 2022

Following Australia

In the USA, the first treatment based on intestinal bacteria transplantation was approved

Svetlana Maslova, Hi-tech+

The Rebyota drug for the treatment of severe intestinal infection was approved. At the moment, this is the second official permission in the world for the clinical use of microbiota transplantation for the treatment of patients. The first one was issued in Australia less than a month ago.

In November of this year, Australia approved the transplantation of fecal microbiota for the treatment of infections caused by Clostridioides difficile bacteria. Now the US regulator FDA reports on a similar permit, which received the drug Rebyota from Ferring Pharmaceuticals, which has been under development for ten years.

Rebyota will be prescribed in a single dosage for the treatment of recurrent Clostridioides difficile infection, writes Stat. This infection, which disrupts the balance of healthy intestinal bacteria, is accompanied by severe diarrhea, fever, nausea and abdominal pain. Severe inflammation of the colon can be life—threatening - in the USA alone, 15-30 thousand patients die from it every year.

Approval of treatment is a huge step forward for about 200 thousand people who suffer from relapses of Clostridioides difficile every year, experts say. According to the results of the third phase of clinical trials, Rebyota reduces the recurrence rate by 29%.

Fecal microbiota transplantation is carried out by delivering donor bacteria orally, using colonoscopy or enemas. Rebyota uses an enema injection.

Currently, another company, Seres Therapeutics, is actively developing in the United States, which in September of this year also filed an application with the FDA for its oral drug for the treatment of Clostridioides difficile. Approval is expected to be received in the spring of 2023.

Today, many diseases are beginning to be associated with the diabalance of intestinal bacteria. For example, recently scientists have shown the relationship between the intestine and the development of obesity and Parkinson's disease. Earlier, similar conclusions were made regarding rheumatoid arthritis and diabetes. It is very likely that microbiota transplantation will be actively studied for their treatment in the coming years.

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