The FDA on Wednesday approved therapy based on faecal transplantation from Swiss company Ferring Pharmaceuticals to reduce the recurrence of bacterial infection, the first such therapy to be licensed in the United States (Andrew Kelly, Reuters)
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WASHINGTON — The Food and Drug Administration on Wednesday approved fecal transplant-based therapy from Switzerland-based Ferring Pharmaceuticals to reduce the recurrence of bacterial infection, making it the first such therapy to be licensed in the states. -United.
The therapy, Rebyota, targets Clostridium difficile, or C. diff – a superbug responsible for infections that can cause severe and life-threatening diarrhea. In the United States, the infection is associated with 15,000 to 30,000 deaths per year.
Although this is the first FDA-approved therapy of its kind for recurrent C. diff infections, fecal microbiota transplants — classified by the regulator as experimental — have long been the standard of care in the United States for this disease.
“As the first faecal microbiota product approved by the FDA, (the action) represents an important milestone, as it provides an additional approved option to prevent recurrent infections (C. diff),” said Peter Marks, director of the Agency Center for Biologics Evaluation. and Research.
Rebyota is delivered through an enema and works by replenishing good gut bacteria through samples of microbes distilled from the feces of healthy donors.
The therapy’s approval follows a positive vote from regulator advisers in September, as most panel members called for the therapy to be standardized.
Ferring, who obtained the therapy through his 2018 purchase of U.S.-based Rebiotix, was not immediately available for comment on the therapy’s price and availability.
Besides Ferring, other companies including Seres Therapeutics, which is developing an oral treatment, are working on similar therapies based on faecal microbiota transplantation.
