FDA Committee Recommends RBX2660 for C. diff Infection

A committee of US Food and Drug Administration (FDA) voted on September 22 to recommend a Biologics License Application for Rebyota (RBX2660) to potentially reduce the recurrence of Clostridioides difficile infection (CDI) after antibiotic treatments.

The investigational microbiota-based live biotherapeutic, developed by Ferring Pharmaceuticals, will potentially reduce recurrent CDI after antibiotic usage.

“Recurrent infection is common, treatment options for recurrence are limited, and the currently recommended treatment regimens can be complex and prolonged,” the FDA briefing document states. Bezlotoxumab is the only “currently approved product for prevention of recurrent CDI, indicated for use in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.” However, the addition of RBX2660 offers patients and physicians an additional option in treatment of recurring CDI infections.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 13 to 4 in favor of the available data being adequate to “support the effectiveness of REBYOTA to reduce the recurrence CDI in adults 18 years of age and older following antibiotic treatment for recurrent CDI.”

—Priyam Vora

Reference:
FDA Briefing Document: Vaccines and Related Biological Products Advisory Committee Meeting. September 22, 2022. [FDA Briefing Document]

For more information on fecal microbiota transplantation as a treatment option for Clostridioides difficile infection, watch this video by Dr Jessica Allegretti, director of the fecal transplant program for recurrent C diff at Brigham and Women’s Hospital in Boston, Massachusetts.