Ferring Inc. announced Health Canada has issued a Notice of Compliance, approving REBYOTA® (fecal microbiota, live), a novel first-in-class microbiome-restoration therapy indicated for the prevention of recurrence of Clostridioides difficile infection (C. diff) in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff.
C. diff is the most common cause of infectious diarrhea in hospitalized patients in the industrialized world, including Canada.Once a person has an initial infection, C. diff 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 cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further recurrences. "REBYOTA is a much needed new therapy that offers hope to the thousands of people who suffer from recurrent C. diff infection each year," said Gail Attara, Chief Executive Officer and Co-Founder, Gastrointestinal Society (www.badgut.org). "REBYOTA has the potential to break the vicious recurrence cycle, thus having a significant effect on patients and caregivers. Its effectiveness can reduce healthcare costs by keeping patients out of the hospital."
"Recurrent C. diff is a debilitating condition, affecting physical, psychological, social, and professional aspects of a patient's life. Until now, patients living with the devastating cycle of recurrent C. diff have had limited approved treatment options in Canada. This frequently leads to long periods of time suffering with incapacitating symptoms that prevent them from leaving their homes and even separating them from immediate family members, or a need to stay on chronic antibiotics to maintain their health," said Dr. Theodore Steiner, Head, Division of Infectious Disease, University of British Columbia, and Principal Investigator, Vancouver General Hospital/UBC. "With the approval of REBYOTA, we finally have a regulatory approved therapy that can help prevent future C. diff. recurrence by restoring the microbiome to a healthier state."
Health Canada's approval of REBYOTA® is based on the results from the clinical program including the randomized, double-blind, placebo-controlled Phase 3 PUNCH™ CD3 trial. The results from the Canadian cohort of the Open Label Study (OLS) of PUNCH CD3 were presented this past week at the Canadian Digestive Disease Week (CDDW) conference in Quebec City. In the Canadian OLS cohort (n=117), treatment success was achieved by 75.2% (88/117) of patients who were administered REBYOTA® after standard-of-care (SoC) antibiotics and sustained clinical response at six months was achieved by 90.9% (80/88) of Canadian participants.
Across 5 studies in the clinical development program,7 encompassing safety data of 978 trial participants through 6 months, REBYOTA® was well tolerated with primarily mild to moderate treatment-emergent adverse events (TEAEs) and most were related to preexisting conditions. Through six months, incidence of TEAEs was similar between REBYOTA recipients compared with placebo (66.4%, n=507/763, REBYOTA; 60.2%, n=50/83, placebo).
"We believe the overall results of the PUNCH-CD clinical program and particularly the results from the Canadian OLS cohort of the study, represent a major breakthrough in harnessing the power of the human microbiome to address significant unmet medical needs. This is the first Health Canada approval of a microbiome restoration therapy that prevents future C. diff recurrences, and the culmination of decades of research and clinical development," said Lee Ferreira, General Manager, Canada, Ferring Inc.
"Today's announcement is a significant milestone for people living with recurrent C. diff infection, and represents a significant step which holds promise that many other diseases might be better understood, diagnosed, and prevented using our rapidly evolving insights on the role of the microbiome in human health and disease." added Brian Clark, Vice President, Global Medical Head of Gastro-Enterology Therapeutic Area, Global Research and Medical, Ferring.
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