The therapy, Rebyota, targets Clostridium difficile, or C. difficile – a superbug responsible for infections that can cause serious and life-threatening diarrhea. While this is the first such therapy approved by the Food and Drug Administration (FDA) for recurrent C. difficile infections, fecal microbiota transplants – classified by the regulator as investigational – have long been the standard of care in the U.S. for this condition. Approval for the therapy comes on the back of a positive vote from the regulator's advisers in September, as most on the panel sought standardization of the therapy. Ferring, which gained the therapy through its 2018 purchase of U.S.-based Rebiotix Inc, was not immediately available for a comment on pricing and availability of the therapy. Besides Ferring, other companies including Seres Therapeutics (MCRB.O), which is developing an oral treatment, are working on similar therapies based on fecal microbiota transplantation.

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