FDA Committee Recommends Approval for Rebyota (RBX2660) to Treat Recurrent C Difficile

This afternoon, a US Food and Drug Administration (FDA) committee voted to recommend a Biologics License Application (BLA) for Rebyota (RBX2660) to treat recurrent Clostridioides difficile infection (CDI).

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Thursday, September 22, to review data supporting the BLA Rebiotix, Inc., filed for the live fecal microbiota.

Rebyota was developed by Ferring Pharmaceuticals to reduce recurrent CDI after antibiotic usage. CDI has a high rate of morbidity and mortality, in addition to draining health care resources. Approximately 500000 Americans contract C diff each year, and 30000 die from this highly resistant bacterium. This burden becomes greater and deadlier with each CDI recurrence.

Just before 4:30 pm, EST, VRBPAC voted on the following questions:

• Are the available data adequate to support the effectiveness of REBYOTA to reduce the recurrence of Clostridioides difficile infection (CDI) in adults 18 years of age and older following antibiotic treatment for recurrent CDI?
• Are the available data adequate to support the safety of REBYOTA when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI?

VRBPAC voted 13 to 4 in favor of the first question, and 12 to 4 in favor of the second, with 1 abstention.

Rebyota is a standardized, stabilized, investigational microbiota-based live biotherapeutic. It reduces the cycle of recurrent C diff infections by restoring the gut microbiome and inhibiting antibiotic-induced dysbiosis. A representative from Rebiotix explained that the therapy is standardized for potency with controlled formula, and stabilized for extended shelf life.

There are other treatments for patients with recurrent CDI, such as fecal microbiota transplantation (FMT). However, FMT is only recommended for patients with multiple recurrences who have also failed applicable antibiotic treatments. Rebyota is intended to treat patients suffering from debilitating CDI, but who may not qualify for FMT.

Rebyota was previously granted Fast Track, Orphan, and Breakthrough Therapy designations by the FDA. The treatment will be administered as a pre-packaged single-dose, consisting of 150 mL microbiota suspension from individual human stool donation.

Risk factors for CDI include antibiotics, proton pump inhibitors, previous CDI, health care exposure, age above 65 years, and comorbid conditions such as malignancy, kidney disease, inflammatory bowel disease, and immunosuppression.