In Brief: US_FDA approves a first-in-class live microbiota-based therapy to prevent recurrent Clostridium difficile infections
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 ofafter antibiotic treatment. During the trial, treatment success was defined as absence of recurrentinfection after 8 weeks. Of those treated with Rebyota, 78% met with success, versus 58% on placebo. Though the difference was modest, the
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