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FDA Approves First Prescription Fecal Transplant

The transplant is intended for hard-to-treat intestinal infections that are linked to 15,000 to 30,000 deaths a year.

Ferring
Ferring

A recent AP News article discussed the FDA’s approval of the very first pharmaceutical-grade fecal transplant to combat intestinal infections. The transplant is called Rebyota, and it’s intended for adults battling infections with Clostridium difficile (C. diff), a potentially lethal bacteria that can cause nausea, cramping and diarrhea. In the past, doctors have treated C. diff with stool samples from healthy donors. However, regulating stool banks and fecal transplant practitioners has become tedious for the FDA, which doesn’t typically regulate such procedures.

Ferring Pharmaceuticals’ new fecal therapy is manufactured in Minnesota, using stool donations that are pre-screened for infections and viruses. In trials, 70% of patients who took Rebyota were relieved of symptoms after eight weeks, compared to 58% of patients who received a placebo. 

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