AGA ‘applauds FDA’ for first approved fecal microbiota biotherapeutic
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Following FDA approval of the first fecal microbiota biotherapeutics for recurrent Clostridoides difficile, the American Gastroenterological Association summarized what this means for gastroenterologists and patients going forward.
Aside from this approval, a press release noted the largest change to previous guidance is that the FDA will now require stool banks that provide fecal microbiota therapy products (FMT) to comply with investigational new drug requirements. In the meantime, health care professionals can continue use of appropriately screened donated stool for patients with recurrent C. diff who do not respond to antibiotic therapies, if they have obtained informed consent from the patient or their legally authorized representative and follow procedures that mitigate potential safety concerns such as appropriate storage and handling of donor stool.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients. This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators,” Phillip I. Tarr, MD, chair of the AGA Center for Gut Microbiome Research and Education Scientific Advisory Board, said in the release. “AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
The AGA will continue to follow-up on long-term effectiveness and safety of patients who receive Rebyota (fecal microbiota, live-jslm; Ferring Pharmaceuticals), FMT and other microbiota-base therapies through its FMT National Registry.
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