WASHINGTON (AP) — U.S. officials have approved the first pharmaceutical-grade version of the so-called fecal transplant procedures that doctors have increasingly used for hard-to-treat intestinal infections.
The Food and Drug Administration on Wednesday approved Rebyota for adults who have trouble fighting off infections with Clostridium difficile, commonly referred to as C. diff, a bacteria that causes nausea, cramps and diarrhea. The infection is particularly dangerous when it recurs and is linked to around 15,000 to 30,000 deaths a year.
For more than a decade, some American doctors have used stool samples from healthy donors to treat the condition. The healthy bacteria from donors̵[ads1]7; guts have been shown to help recipients fight off C. diff bacteria. The procedure has become more common as many patients no longer respond to traditional antibiotics.
But the proliferation of stool banks and fecal transplant practitioners across the country has created regulatory headaches for the FDA, which does not traditionally regulate doctors’ medical procedures. The FDA has rarely intervened, provided stool donors are carefully screened for potential infectious diseases.
The new therapy from Ferring Pharmaceuticals Inc. is produced at a facility in Minnesota from stool donations that are screened for dozens of infections and viruses. The therapy is delivered via the rectum by healthcare professionals as a one-off procedure.
The FDA said it approved the treatment based on results from two studies in which 70% of patients who took Rebyota saw their symptoms disappear after eight weeks, compared with 58% of patients who received a placebo.
The new treatment is only for patients who have already taken a course of antibiotics for recurrent infection. The condition is more common in the elderly and people with weakened immune systems.
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