FDA okays first human stool therapy

Ferring’s approval was based on the phase 3 PUNCH CD3 clinical trial, in which 177 adults received Rebyota and 85 placebo. All participants had previously experienced a recurrent bout of C. difficile after antibiotic treatment. During the trial, treatment success was defined as absence of recurrent C. difficile infection after 8 weeks. Of those treated with Rebyota, 78% met with success, versus 58% on placebo. Though the difference was modest, the FDA advisory panel voted in favor of approving the drug.

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