NJ-FERRING-PHARMA
Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a positive vote for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of C. difficile infection (CDI) after antibiotic treatment.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220922005907/en/
VRBPAC voted 13 to 4 that the data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of CDI in adults 18 years of age and older following antibiotic treatment for recurrent CDI. The Committee also voted 12 to 4 with 1 abstention that the data were adequate to support the safety of RBX2660 when administered to adults 18 years of age and older following antibiotic treatment for recurrent CDI. The advisory committee provides recommendations to the FDA, which the agency may consider but is not required to follow, when making its decision.
“Patients with recurrent C. difficile infection currently have limited treatment options,” said 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 data from the biologics license application (BLA) for RBX2660. The clinical development program for RBX2660 included six studies with a total of 1061 participants, of which 978 were treated 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,” said Mirjam Mol-Arts, Executive Vice President, Chief Medical Officer, Ferring Pharmaceuticals.
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 often is 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
About RBX2660
RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrence of 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.
Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.
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.
References:
- 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220922005907/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EIG’s MidOcean Energy Completes Acquisition of Interest in Canada from PETRONAS17.12.2025 09:58:00 CET | Press release
MidOcean Energy (“MidOcean”), a liquefied natural gas (LNG) company formed and managed by EIG, a leading institutional investor in the global energy and infrastructure sectors, today announced the completion of its acquisition of a 20% interest in PETRONAS’ key entities in Canada. The transaction includes a 20% interest in the North Montney Upstream Joint Venture (“NMJV”), which holds PETRONAS’ upstream investment in Canada, and a 20% interest in the North Montney LNG Limited Partnership (“NMLLP”), which holds PETRONAS’ 25% participating interest in the LNG Canada Project. This strategic investment positions MidOcean across the LNG value chain, securing upstream resources and downstream liquefaction through the LNG Canada Project, with around 0.7 MTPA of associated LNG and potential to grow further. RBC Capital Markets acted as financial advisor to MidOcean, and Latham & Watkins acted as legal advisor. About EIG EIG is a leading institutional investor in the global energy and infrastru
Nexo Announces Landmark Crypto Partnership with Tennis Australia for Australian Open and Summer of Tennis17.12.2025 09:00:00 CET | Press release
Nexo has signed a landmark multi-year deal with Tennis Australia, covering the Australian Open and the Summer of Tennis. The partnership delivers exclusive experiences, including a feature in the Coachеs Pod. The announcement continues Nexo’s rapid global expansion, following three other major sports partnerships in 2025. Nexo, the premier digital assets platform, has entered a landmark multi-year global partnership with Tennis Australia, becoming the Official Crypto Partner of the Australian Open and the Summer of Tennis, including the United Cup, Adelaide International, Brisbane International, and Hobart International. This agreement marks the first time a digital asset company has partnered with a Grand Slam tournament, affirming Nexo’s prestige, long-term vision, and leadership at the intersection of elite sport and digital assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216497915/en/ Antoni Trenchev, Co-founde
Outpost24 Secures New Investment to Scale its Exposure Management and Identity Security Solutions17.12.2025 08:00:00 CET | Press release
The strategic funding from international investment firm Vitruvian Partners will advance the company’s platform, helping organizations rapidly transform threat data into decisive action and a more robust security posture. Outpost24, a leader in exposure management and identity security, today announced a new investment from Vitruvian Partners to fuel its next phase of global growth. This significant new funding will accelerate innovation across the company's platform, with a focus on integrating AI capabilities to optimize how security teams identify and neutralize critical vulnerabilities. The only European vendor recognized as an overall leader in the 2025 KuppingerCole Leadership Compass Report for Attack Surface Management, Outpost24 delivers a distinct approach to cyber defence that empowers security teams to gain a complete understanding of their digital and human risk landscape. Last week, Outpost24 announced the acquisition of Infinipoint, a specialist in device identity, postu
VeritasChain Unveils VAP Architecture, New Auditability Research, and Confirms Submissions to 58 Regulators Globally17.12.2025 08:00:00 CET | Press release
VeritasChain today unveiled its Verifiable AI Provenance Framework (VAP) architecture, published new research on verifiable audit trails, and confirmed informational submissions to 58 regulatory authorities across 43 jurisdictions. These milestones advance VeritasChain’s mission to establish a global framework for verifiable auditability in AI and algorithmic trading. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216433807/en/ Map indicates jurisdictions where regulatory outreach or informational submissions have been made as of Dec 2025. Verifiable AI Provenance Framework (VAP) VAP is a layered assurance architecture designed for independent verification of AI decision-making. It is not a single product, but a framework defining how cryptographic evidence and third-party verification interoperate across diverse systems. The architecture records decision-to-execution events as immutable audit trails, facilitating regulat
New Published Data Confirms Nemluvio® (Nemolizumab) Can Rapidly Relieve Itch and Improve Sleep in as Early as Two Days in Both Atopic Dermatitis and Prurigo Nodularis17.12.2025 07:00:00 CET | Press release
Post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs, published in the Journal of the European Academy of Dermatology and Venereology, highlight nemolizumab’s fast onset of action and improvement of itch and sleep disturbance in patients with moderate-to-severe atopic dermatitis and prurigo nodularis1 Significant improvements in itch were observed as early as 48 hours after initial treatment and steadily increased through to Day 141 Nemolizumab is the first approved monoclonal antibody that specifically targets and inhibits the signalling of IL-31 – a neuroimmune cytokine that drives itch and other symptoms in atopic dermatitis and prurigo nodularis2-4 Nemolizumab is approved by multiple regulatory authorities around the world for the treatment of moderate-to-severe atopic dermatitis and prurigo nodularis, including in the U.S. and EU5,6 Galderma (SIX: GALD), the pure-play dermatology category leader, today released new clinical data confirming nemolizumab’s r
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom