Ferring's Rebyota wins microbiota race with FDA approval
The US Food and Drug Administration (FDA) has approved its first fecal microbiota product in the shape of Rebyota (fecal microbiota, live-jslm).
Privately-held Swiss drugmaker Ferring’s live biotherapeutic is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in adults, following antibiotic treatment for recurrent CDI.
"A major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs"Rebyota is administered rectally as a single dose, having been prepared from stool donated by qualified individuals. Its approval has been heralded as a milestone for biopharma as a whole as well as for recurrent CDI, which represents a significant burden for patients, caregivers and the healthcare system.
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