Rebyota Passes Through FDA To Become First Approved Fecal Microbiota Product

The US FDA has given its blessing to Ferring Pharmaceuticals’ Rebyota, making it the first fecal microbiota product approved by the drug regulator. 

Rebyota (previously RBX2660) is indicated for the prevention of the recurrence of Clostridiodes difficile infection (CDI) in patients aged 18 and older who have completed antibiotic treatment for recurrent CDI. Its application has been granted Fast Track, Breakthrough Therapy, and Orphan designations by the FDA. 

“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening. As the first FDA-approved fecal microbiota product, today’s action represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

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Restoring Gut Flora

Caused by the C. difficile bacterium, CDI is a potentially fatal disease that results in diarrhea and severe inflammation in the colon. In the US, it is linked to 15,000 – 30,000 deaths annually. 

CDI could arise when the balance of microorganisms in the gut is disrupted, which could happen when taking antibiotics. C. difficile exploits imbalances by multiplying and releasing toxins that damage the body. CDI could become recurrent, while the risk of additional recurrences increases with each infection. 

Rebyota is designed to restore the balance of the gut flora or prevent further episodes of CDI. The drug is prepared from stool donated by qualified individuals and is administered rectally as a single dose. 

While both donors and the donated stool are tested for transmissible pathogens, Rebyota still carries the risk of transmitting infectious agents. The drug may also contain food allergens, but according to the FDA, the potential for Rebyota to cause allergic reactions due to food is unknown. 

The safety of Rebyota was assessed from a Phase 3, a Phase 2b, and open-label clinical trials in the US and Canada. The trials enrolled patients with a history of recurrent CDI. Following antibiotic treatment to control the infection, the patients were given Rebyota or placebo. In one study, the most common side effects included abdominal pain, diarrhea, abdominal bloating, gas, and nausea.

An analysis of the Phase 3 study, which borrowed data from the similarly-designed Phase 2b estimated the treatment success rate of Rebyota at eight weeks was 70.6% versus 57.5% for placebo. The results were shown to be statistically significant. More than 90% of participants were CDI-free in a follow-up at six months.

Author

Joy Lin

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