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RBX2660 is the first live microbiota therapeutic approved by the FDA.
Years of research and clinical trials finally culminating in the approval of RBX2660 (Rebyota) by the US Food and Drug Administration (FDA) for the prevention of recurrent Clostridioides difficile infections (rCDI) in adult patients who completed a primary antibiotic series.
The approval represents the first live microbiota therapeutic ever to gain the FDA green light.
The treatment, developed by Ferring Pharmacueticals, is prepared from stool donated by qualified individuals and administered rectally as a single dose. RBX2660 is a standardized, stabilized, investigational microbiota-based live therapeutic.
In an interview with HCPLive®, Sahil Khanna, MBBS, MS, Division of Gastroenterology and Hepatology, Mayo Clinic, discussed his excitement by the FDA approval and how the treatment could go a long way toward making C difficile infections a thing of the past.
“I did my little happy dance in my office,” Khanna said after hearing of the approval. “A lot of my friends texted me. I think this is such a big achievement for the field of medicine in general.”
While this is the first approval for such a product, it is likely that it won’t be the last as at least 1 more live microbiota therapeutic has a Prescription Drug User Fee Act (PDUFA) date set for the first half of 2023.
However, the Khanna said you can’t overstate how important it is for doctors to now have options for treating recurrent CDI in a hospital setting.
“I’m hoping that recurrent C difficile infection becomes a thing of the past,” Khanna said.