The FDA approved the microbiota-based live biotherapeutic RBX2660 (Rebyota, Ferring) to prevent recurrent Clostridioides difficile infection (CDI) following standard-of-care antibiotics.
The approval was based on results of the phase 3 PUNCH CD3 trial that showed a sustained response through six months, according to results presented at IDWeek 2022. Researchers conducted a randomized, double-blind, placebo-controlled phase 3 study that included a Bayesian primary analysis