WASHINGTON (AP) — U.S. officials have approved the first pharmaceutical-grade version of so-called fecal transplant procedures that doctors are increasingly using for difficult-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 known 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 per year.
For more than a decade, some American doctors have used stool samples from healthy donors to treat the disease. Healthy bacteria in the gut of donors 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 doesn’t traditionally regulate doctors’ medical procedures. The FDA rarely intervened, provided that stool donors were carefully screened for possible infectious diseases.
Ferring Pharmaceuticals Inc.’s new therapy is made in a Minnesota facility from donated stool that is screened for dozens of infections and viruses. The therapy is administered rectally by medical professionals all at once.
The FDA said it approved the treatment based on the results of two studies in which 70% of patients taking Rebyota saw their symptoms disappear after eight weeks, compared with 58% of patients taking a placebo.
The new treatment is reserved for patients who have already taken a course of antibiotics for a recurring infection. The condition is more common in older people and people with weakened immune systems.
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Science and Education Media Group. The AP is solely responsible for all content.