FDA Committee Issues Positive Vote for RBX2660 in Recurrent Clostridioides difficile Infection

An FDA advisory committee recently issued a positive vote for Ferring’s RBX2660, an investigational microbiota-based live biotherapeutic, for its potential in reducing recurrent Clostridioides difficile infection (CDI) after antibiotic treatment.

Based on data of 6 studies included in the biologics license application (BLA) for RBX2660, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 13 to 4 that the data were adequate to support the effectiveness of the drug to reduce the recurrence of CDI in adults 18 years of age and older following antibiotic treatment for recurrent CDI.

The committee additionally voted 12 to 4, with 1 abstention, that the data were adequate to support the safety of RBX2660 when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI.

“Patients with recurrent CDI currently have limited treatment options,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine, in Ferring’s accompanying press release. “The committee’s vote is a step toward potentially addressing the debilitating cycle of recurrence and the suffering faced by these patients.”

Cited by the CDC as an urgent public health threat, an estimated 453,000 cases of CDI occur per year in the United States. Severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis are all known symptoms of CDI, in which recurrent infection is associated with substantial morbidity and mortality.

Along with poor health outcomes among patients, CDI poses a significant burden for caregivers and the health care system. A recent study highlighted the public health impact of CDI with as much as $4.8 billion attributed to acute care facilities due to extended length of stay and associated costs. Risk factors for CDI include the hospital setting, having previously had CDI, and being older than 65.

Developed by Rebiotix, a Ferring company, RBX2660 has previously been granted Fast Track, Orphan, and Breakthrough Therapy designations from the FDA. The agency will now consider the positive vote issued by the advisory committee in making its final decision on approval.

“Today’s advisory committee vote represents an important milestone in Ferring’s ongoing efforts to address the unmet need for interventions that can reduce the incidence of recurrent CDI, which represents a significant health burden for patients,” said Mirjam Mol-Arts, executive vice president and chief medical officer, Ferring.