FDAapproves the first fecal microbiota product for recurrent C difficile MedTwitter
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.Treatment options for recurrent CDI are limited. It's been estimated that up to one third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI. Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1000 participants, the company notes in a
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