Ferring Announces U.S. FDA Advisory Committee Meeting for RBX2660 its Investigational Microbiota-Based Live Biotherapeutic
Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) will hold a meeting on September 22, 2022, to review data supporting the biologics license application (BLA) for RBX2660, a microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.
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“The gut microbiome is a highly diverse community of microbes that plays an essential role in human health. Emerging research has shown the promise of leveraging the microbiome to address a range of conditions, including serious diseases such as recurrent C. difficile infection,” said Elizabeth Garner, Chief Scientific Officer, Ferring Pharmaceuticals, U.S. “The cycle of recurrent CDI represents a significant public health burden, and Ferring is working to address that unmet need.”
The FDA intends to live stream the advisory committee meeting on the agency's YouTube page, and the meeting will also be webcast from the FDA website.
About C. difficile infection
C. difficile infection (CDI) is a serious and potentially deadly disease 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).1 Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, CDI causes an estimated half a million illnesses and tens of thousands of deaths in the U.S. alone each year.1,2,3
C. difficile infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.4,5 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.6,7,8,9 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.8,9
RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection after antibiotic treatment. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). RBX2660 was developed by Rebiotix, a Ferring company.
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 maternal 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.
Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. Ferring is working to develop novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.
- Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
- Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html
- Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
- Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
- Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
- Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
- Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. Published online March 11, 2021.
- Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
- Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
- Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.
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