As the first FDA-approved fecal microbiotica product, Rebyota represents a significant milestone, potentially clearing the way for other such treatments.
“We believe this is a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs,” Per Falk, president of Ferring, said in a release. “(This) presents a significant step which holds promise that many other diseases might be better understood, diagnosed, prevented and treated using our rapidly evolving insights.”
C. diff. is a superbug that resists antibiotics and other medications. The disorder causes roughly 500,000 illnesses and between 15,000 and 30,000 deaths annually in the U.S.
To address C. diff., patients have turned to loosely regulated, investigational fecal microbiota transplants (FMTs), which use healthy bacteria from the feces of donors and are performed through a colonoscopy or upper endoscopy.
Ferring picked up the treatment in the 2018 acquisition of Minnesota-based Rebiotix. This September, an FDA advisory committee voted 13-4 to recommend Rebyota for an approval, which would help standardize treatment.