FDA approves Rebyota, Ferring's poop-based drug to fight C. diff infection
The FDA approved Ferring Pharmaceuticals’ Rebyota drug on Wednesday, a poop-based drug implant that can prevent the recurrence of Clostridioides difficile infection.
While the use of fecal microbiota transplantation (FMT) — replenishing a patient’s gut with bacteria from healthy feces — has already been happening without an FDA-approved product, Rebyota is the first live biotherapeutic drug approved by the agency to fight the potentially deadly infection.
Rebyota works by repopulating the gut microbiome. The transplanted microbes then fight with the C. diff infection, preventing it from growing and forcing it out of the gut.
The drug has been approved for people 18 years of age and older who have already completed antibiotic treatment for C. diff infections that continue to come back.
Clostridioides difficile is a bacteria that causes life-threatening diarrhea. It is usually a side effect of taking antibiotics long term and can easily spread from person to person. The infection occurs most often in people 65 and older who take antibiotics, those staying in hospitals and nursing homes for a long period of time and in people with weakened immune systems.
In clinical trials, the overall estimated rate of success in preventing recurrent CDI through eight weeks was significantly higher in the Rebyota group (70.6%) than in the placebo group (57.5%).
Safety has been a key concern with introducing donor fecal matter into a person’s microbiome. Prior to Ferring’s Phase III announcement, the FDA had flagged the potential risk of serious or life-threatening infections with FMT.
The agency several days ago also recently tightened its enforcement policy around FMT, noting, “FDA does not intend to extend enforcement discretion with respect to the IND requirements for distribution of FMT products obtained from stool banks.”
Ferring is not the only company trying to break into the poop-based drug landscape, but the only one successful with the FDA so far.
In March 2022, the FDA slapped a clinical hold on Finch Therapeutics’ testing of oral “crapsules” that also use bacteria strains extracted from donor stool in order to treat C. diff, over fears that stool samples might be able to transmit SARS-CoV-2 between patients. The hold was eventually lifted in April. Seres Therapeutics is also developing a microbiome treatment for C. diff. In October, the FDA gave a PDUFA date of April 26, and according to the biotech, the agency is not planning on an adcomm.
Editor’s note: Article updated to note that Rebyota is the first live biotherapeutic to fight C diff, not the first drug approved to fight this infection.