FDA Approves First-in-Class Microbiota-Based Live Biotherapeutic for C. Difficile Infection

Summary-

• The FDA has approved fecal microbiota, live-jslm (Rebyota; Ferring Pharmaceuticals) for the prevention of recurring Clostridioides difficile infection (CDI) among patients 18 years of age and older after an antibiotic treatment for recurrent CDI. 
• Live-jslm (Rebyota; Ferring Pharmaceuticals) is indicated for the prevention of recurring Clostridioides difficile infection among patients 18 years of age and older after an antibiotic treatment.
• The safety and efficacy of REBYOTA was studied in the largest clinical trial program in the field of microbiome-based therapeutics, including five clinical trials with more than 1,000 participants
• Recurrent CDI represents a significant burden for patients, caregivers and the healthcare system

The novel, first-in-class, microbiota-based live biotherapeutic comes in a pre-packaged, single-dose, 150 mL microbiota suspension for rectal administration. Rebyota is sourced from qualified donors and tested for a panel of transmissible pathogens.

“Until now, patients living with the devastating cycle of recurrent C. difficile infection have had limited FDA-approved treatment options, causing them to suffer long periods of time with debilitating symptoms that prevent them from leaving their homes and even separate them from immediate family members,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine, in a press release.

The FDA approval of REBYOTA is based on the results from the clinical program including the randomized, double-blind, placebo-controlled Phase 3 PUNCH™ CD3 trial in which a single dose of REBYOTA demonstrated superiority to placebo as a treatment to reduce recurrence of CDI after standard-of-care antibiotic treatment. Two hundred sixty-two (262) trial participants received blinded treatment (n=177, REBYOTA; n=85, placebo) and the primary endpoint was treatment success, defined as the absence of CDI diarrhea within eight weeks after completing study treatment. The Bayesian model-estimated treatment success rate at eight weeks for REBYOTA was 70.6% versus 57.5% for placebo, with a 99.1% posterior probability that REBYOTA was superior to placebo in reducing recurrent CDI after standard-of-care antibiotic treatment.¹ More than 90% of study participants who achieved treatment success remained free of CDI recurrence through six months.

About C. difficile Infection (CDI)

CDI is a serious and potentially deadly infection that impacts people across the globe. The C. difficile bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).CDI can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system. It has been estimated that up to 35% of CDI cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections. After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.Antibiotics – the current standard of care for treatment of CDI – treat the disease but can also be a contributing factor for a vicious cycle of recurrence, causing a significant burden for patients suffering from this debilitating and potentially deadly illness.

ABOUT REBYOTA

REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. REBYOTA is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration. REBYOTA is sourced from qualified donors and tested for a panel of transmissible pathogens.

INDICATION

REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff.

Limitation of Use:

REBYOTA is not indicated for the first occurrence of C. diff.

IMPORTANT SAFETY INFORMATION

• You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g. anaphylaxis) to REBYOTA or any of its components.
• You should report to your doctor any infection you think you may have acquired after administration.
• Prior to treatment with REBYOTA, talk to your doctor about the possibility of a sudden allergic reaction following administration.
• Talk to your doctor about any known food allergies.
• Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%).
• REBYOTA has not been studied in patients below 18 years of age.
• Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately owned Ferring now employs around 6,000 people worldwide, has its own operating subsidiaries in more than 50 countries, and markets its products in 110 countries.

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