💰 U.S. FDA gives first-ever approval to fecal transplant therapy

TL;DR

Nov 30 (Reuters) - The U.S. health regulator on Wednesday approved Switzerland-based Ferring Pharmaceuticals' fecal transplant-based therapy to reduce the recurrence of a bacterial infection, making it the first therapy of its kind to be cleared in the United States.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.Rebyota is delivered through an enema and works by replenishing good gut bacteria through samples of microbes distilled from faeces of healthy donors.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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