Ferring Pharmaceuticals today announced that REBYOTA™ (fecal microbiota, live – jslm) is now available in the United States (U.S.). REBYOTA is the first and only microbiome-based treatment approved by the U.S. Food and Drug Administration (FDA) to prevent recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection.
“With the launch of REBYOTA, Ferring is proud to offer an urgently needed new treatment option for adults suffering from the burden of recurrent C. diff infection,” said Brent Ragans, President, Ferring Pharmaceuticals U.S.
REBYOTA was approved by the U.S. FDA on November 30, 2022. The efficacy and safety 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. REBYOTA is a single-dose treatment that is administered in minutes during one visit at the doctor’s office.
“The availability of REBYOTA is great news for people who are suffering from the devastating cycle of recurrent C. diff infection,” said Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., Yale University School of Medicine. “Healthcare providers can now offer an FDA-approved microbiome treatment and provide patients with new hope to help fight this infection.”
C. diff infection is a serious and potentially deadly infection that impacts people across the globe. The C. diff bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon).
C. diff infection 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 C. diff infection 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 C. diff infection – 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.
Resources for Patients
Ferring provides a variety of offerings, including co-pay and patient assistance programs, to allow for access to REBYOTA. Information about the REBYOTA programs is available from healthcare providers or at REBYOTA.com.
Resources for Healthcare Providers
Ferring offers educational programs as well as support programs for healthcare providers. The REBYOTA CONNECT program provides guidance to healthcare providers about access services, as well as information about co-pay and patient assistance programs. Information is available at REBYOTAHCP.com.