Saint-Prex, Switzerland & Parsippany, N.J., United States:
- Vaccines and Related Biological Products Advisory Committee reviewed information from the biologics license software for RBX2660
- RBX2660 is an investigational microbiota-based reside biotherapeutic studied for its potential to cut back recurrence of C. difficile an infection after antibiotic remedy
- Recurrent C. difficile an infection represents a big burden for sufferers, caregivers, and the healthcare system
Ferring Pharmaceuticals as we speak introduced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a constructive vote for RBX2660, an investigational microbiota-based reside biotherapeutic studied for its potential to cut back recurrence of C. difficile an infection (CDI) after antibiotic remedy.
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VRBPAC voted 13 to 4 that the info had been enough to assist the effectiveness of RBX2660 to cut back the recurrence of CDI in adults 18 years of age and older following antibiotic remedy for recurrent CDI. The Committee additionally voted 12 to 4 with 1 abstention that the info had been enough to assist the security of RBX2660 when administered to adults 18 years of age and older following antibiotic remedy for recurrent CDI. The advisory committee offers suggestions to the FDA, which the company might think about however isn’t required to observe, when making its resolution.
“Patients with recurrent C. difficile infection currently have limited treatment options,” mentioned Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine.“The committee’s vote is a step toward potentially addressing the debilitating cycle of recurrence and the suffering faced by these patients.”
The committee reviewed information from the biologics license software (BLA) for RBX2660. The medical improvement program for RBX2660 included six research with a complete of 1061 contributors, of which 978 had been handled with RBX2660.
“Today’s advisory committee vote represents an important milestone in Ferring’s ongoing efforts to address the unmet need for interventions that can reduce the incidence of recurrent C. difficile infection, which represents a significant health burden for patients,” mentioned Mirjam Mol-Arts, Executive Vice President, Chief Medical Officer, Ferring Pharmaceuticals.
About C. difficile an infection
C. difficile an infection (CDI) is a severe and doubtlessly lethal illness that impacts individuals throughout the globe. The C. difficile bacterium causes debilitating signs corresponding to extreme diarrhea, fever, abdomen tenderness or ache, lack of urge for food, nausea, and colitis (an irritation of the colon).1 Declared a public well being menace by the U.S. Centers for Disease Control and Prevention (CDC) requiring pressing and rapid motion, CDI causes an estimated half one million sicknesses and tens of hundreds of deaths within the U.S. alone annually.1,2,3
C. difficile an infection typically is the beginning of a vicious cycle of recurrence, inflicting a big burden for sufferers and the healthcare system.4,5 It has been estimated that as much as 35% of CDI instances recur after preliminary analysis and individuals who have had a recurrence are at considerably larger threat of additional infections.6,7,8,9 After the primary recurrence, it has been estimated that as much as 65% of sufferers might develop a subsequent recurrence.8,9
RBX2660 is an investigational microbiota-based reside biotherapeutic studied for its potential to cut back recurrence of C. difficile an infection after antibiotic remedy. 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 firm.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a analysis pushed, specialty biopharmaceutical group dedicated to serving to individuals all over the world construct households and reside higher lives. Headquartered in Saint-Prex, Switzerland, Ferring is a frontrunner in reproductive medication and maternal well being, and in specialty areas inside gastroenterology and urology. Ferring has been growing remedies for moms and infants for over 50 years and has a portfolio protecting remedies from conception to start. Founded in 1950, privately owned Ferring now employs round 6,000 individuals worldwide, has its personal working subsidiaries in additional than 50 nations, and markets its merchandise in 110 nations.
Learn extra at www.ferring.com, or join with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.
Ferring is dedicated to exploring the essential hyperlink between the microbiome and human well being, starting with the specter of recurrent C. difficile an infection. Ferring is working to develop novel microbiome-based therapeutics to deal with important unmet wants and assist individuals reside higher lives. Connect with us on our devoted microbiome therapeutics improvement 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 an infection within the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
- Nelson WW, et al. Health care useful resource utilization and prices of recurrent Clostridioides difficile an infection within the aged: a real-world claims evaluation. J Manag Care Spec Pharm. Published on-line March 11, 2021.
- Kelly, CP. Can we establish sufferers at excessive threat of recurrent Clostridium difficile an infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
- Smits WK, et al. Clostridium difficile an infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
- Leong C, Zelenitsky S. Treatment methods for recurrent Clostridium difficile an infection. Can J Hosp Pharm. 2013;66(6):361-368.