SAINT-PREX, SWITZERLAND & PARSIPPANY, NJ–(BUSINESS WIRE). from C. difficile Infection (CDI) after antibiotic treatment.
VRBPAC voted 13 to 4 that the data are adequate to support the efficacy of RBX2660 in reducing CDI recurrence in adults 18 years and older after antibiotic treatment for recurrent CDI. The committee also voted 12 to 4 with 1 abstention that the data are sufficient to support the safety of RBX2660 when administered to adults 18 years and older following antibiotic treatment for recurrent CDI. The Advisory Committee makes recommendations to the FDA that the agency may consider in making its decision, but is not required to follow.
“Patients with recurrent C. difficile Infections currently have limited treatment options,” said Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine. “The committee’s vote is a step towards potentially addressing the debilitating cycle of relapse and suffering in these patients.”
The committee reviewed the data from the Biologics License Application (BLA) for RBX2660. The clinical development program for RBX2660 included six studies involving a total of 1061 participants, 978 of whom were treated with RBX2660.
“Today’s Advisory Committee vote marks an important milestone in Ferring’s ongoing efforts to address the unmet need for interventions that can reduce the incidence of relapse C. difficile infection that poses a significant health burden to patients,” said Mirjam Mol-Arts, executive vice president, chief medical officer, Ferring Pharmaceuticals.
Around C. difficile infection
C. difficile Infection (CDI) is a serious and potentially fatal disease that affects people around the world. That 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 CDI has been declared a public health threat by the US Centers for Disease Control and Prevention (CDC) and requires urgent and immediate action. In the US alone, CDI is estimated to cause half a million illnesses and tens of thousands of deaths each year.1,2,3
C. difficile Infection is often the start of a vicious cycle of recurrence that places a significant burden on 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 relapsed are at significantly higher risk of further infection.6,7,8,9 After the first recurrence, it is estimated that up to 65% of patients may develop a subsequent recurrence.8.9
RBX2660 is a living microbiota-based biotherapeutic that has been evaluated for its potential to reduce the recurrence of C. difficile Infection after antibiotic treatment. RBX2660 has received Fast Track, Orphan and Breakthrough Therapy designations from the US 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 dedicated to helping people around the world raise families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive and maternal health, as well as specialties in gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio spanning treatments from conception to birth. Founded in 1950, Ferring is a private company with around 6,000 employees worldwide, has its own operating subsidiaries in more than 50 countries and sells its products in 110 countries.
Learn more at www.ferring.com or contact us at TwitterFacebook, Instagram, LinkedIn and YouTube.
Ferring is committed to exploring the critical link between the microbiome and human health, beginning with the risk of recurrence C. difficile Infection. Ferring works to develop novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Contact us on our dedicated microbiome therapeutics development channels 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, November 14, 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html
Fitzpatrick F, Barbut F. Breaking the cycle of recurring Clostridium difficile. Clin Microbiol Infect. 2012;18(Supplement 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. Healthcare resource utilization and recurring costs Clostridioides difficile Infection in the elderly: a real claims analysis. J Manage Care Spec Pharm. Published online March 11, 2021.
Kelly, CP. Can we identify patients at high risk of recurrence? Clostridium difficile Infection? Clin Microbiol Infect. 2012; 18 (Supplement 6): 21-27.
WK Smits et al. Clostridium difficile Infection. Nat Rev Dis primer. 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.