Microbiota Restoration Tx Designated Breakthrough Therapy for CDI
Rebiotix announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RBX2660, a Microbiota Restoration Therapy (MRT), for the treatment of recurrent Clostridium difficile infection (CDI).
MRT is Rebiotix's drug platform for delivering healthy, live, human-derived microbes into a patient's intestinal tract to treat diseases such as CDI. Studies have shown that most CDI cases occur after antibiotics disrupt the normal gastrointestinal flora. Restoring the microbial balance in the gut is thought to be key to breaking the cycle of recurrence.
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