FDA Approval of First Fecal Microbiota Product Ensures Safety in Standardization

Last week, the US Food and Drug Administration (FDA) approved the first-ever fecal microbiota product—Ferring’s RBX2660 (Rebyota) for recurrent Clostridioides difficile infection (CDI).

There has been a great deal of anticipation surrounding this approval, because, as Ferring’s Chief Scientific Officer Elizabeth Garner, MD, explains, “it’s about 30% likely that a person who gets C diff will have a recurrence of that C diff, and if a person has a recurrence, they’re about +60% more likely to have yet another recurrence.

RBX2660 is a treatment for the prevention of recurrent CDI, and it works by restoring the gut microbiome after it was disrupted by C difficile. Garner explains a fact that antimicrobial stewards know well: powerful antibiotics, though very useful, can kill off the healthy bacteria and leave the dangerous bacteria to flourish unchecked.

Rebyota takes bacteria (via stool sample) from individuals with a healthy gut microbiome. After extensive processing, the treatment is administered to patients at high risk of recurrent CDI.

Garner emphasized that what makes the FDA approval of RBX2660 so important is that it ensures the treatment will be standardized in a way antibiotics and fecal microbiota transplant (FMT) are not.

“What, really, the approval of RBX gives us is a standardized process,” said Garner. “This allows for rigorous, consistent screening processes, and also allows us now with an approved product to have safety surveillance over time.”

Garner hopes the FDA stamp of approval will allow patients and providers to trust in the safety and efficacy of RBX2660. Every aspect of the treatment has been analyzed and standardized.

“This product has been taken all the way through that FDA process,” Garner said. “We know the FDA has looked at every piece of this.” The approval of RBX2660 provides a new treatment option to patients struggling with C difficile, but it also ensures a standard of safety and efficacy.

This is part 1 of an interview with Dr. Elizabeth Garner. Come back tomorrow for part 2, in which Garner discusses the intended patient population for RBX2660 and the next steps for this treatment.