Business Wire

NJ-FERRING-PHARMA

Share
Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660

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:

  1. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
  2. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html
  3. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
  4. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  5. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
  6. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
  7. 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.
  8. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
  9. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
  10. 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

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

NIKE, Inc. Board of Directors Announces Long-Time Nike Veteran Elliott Hill to Return as President and Chief Executive Officer John Donahoe to Retire from Nike19.9.2024 22:15:00 CEST | Press release

The Board of Directors of NIKE, Inc. (NYSE:NKE) announced today that Elliott Hill will become President and Chief Executive Officer of NIKE, Inc., effective October 14, 2024. Hill will also become a Director of the NIKE, Inc. Board of Directors and a member of the Executive Committee. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919388699/en/ Incoming NIKE, Inc. President & CEO Elliott Hill (Photo: Business Wire) “I am excited to welcome Elliott back to NIKE. Given our needs for the future, the past performance of the business, and after conducting a thoughtful succession process, the Board concluded it was clear Elliott’s global expertise, leadership style, and deep understanding of our industry and partners, paired with his passion for sport, our brands, products, consumers, athletes, and employees, make him the right person to lead Nike’s next stage of growth,” said Mark Parker, Executive Chairman of NIKE, Inc. “Pers

Andersen Global styrker båndene i Asien med yderligere medlemsvirksomheder19.9.2024 20:53:00 CEST | Pressemeddelelse

Andersen Global tilføjer medlemsvirksomheder i Asien og Stillehavsområdet, hvor VDB Loi-kontorerne i Cambodja og Vietnam tager Andersen-brandet i brug. Andersen i Cambodja og Andersen i Vietnam har under ledelse af Managing Partner Jean Loi og Senior Partner Edwin Vanderbruggen arbejdet i regionen i mere end 10 år. De udbyder en omfattende suite af skatterelaterede og juridiske tjenester, herunder inden for bankvæsen og finans, fusioner og opkøb, virksomhedsrådgivning, skatterådgivning, transfer pricing og tvister og retssager. "Efterhånden som det økonomiske landskab udvikler sig og bliver mere komplekst, går vores kunders forventninger og behov samme vej," siger Edwin. "Ved at blive medlemsvirksomhed i Andersen Global styrker vi vores evne til at levere branchens bedste integrerede service i hele Cambodja og Vietnam. Ved at tage brandet i brug kan vi også accelerere vores vækst, hvilket sætter os i stand til at navigere i et meget indviklet marked med uovertruffen ekspertise." "Med s

Mary Kay Expands Into Kyrgyzstan, Further Elevating Beauty and Empowerment Around the World19.9.2024 19:03:00 CEST | Press release

Mary Kay Inc., a global leader in skin care and cosmetics, is proud to announce its expansion into Kyrgyzstan, marking a significant milestone in its ongoing international growth strategy. This exciting development underscores Mary Kay’s commitment to empowering women and providing innovative, high-quality skincare and beauty products across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919159057/en/ Mary Kay’s expansion into Kyrgyzstan marks another step forward in the company’s mission to enrich women’s lives around the world, offering top-tier beauty products and unparalleled business opportunities. (Photo: Mary Kay Inc.) The beauty and personal care market is experiencing robust growth internationally, with sales volume in these categories almost doubling over the past several years. The beauty market is expected to reach approximately $580 billion by 2027, growing by a projected 6 percent per year1 while

Xsolla Partners With AbleGamers for Charity Campaign at TwitchCon 202419.9.2024 19:00:00 CEST | Press release

Collect Limited Edition Pins at TwitchCon and Help Us Raise Up To $10,000 for AbleGamers Xsolla, a global video game commerce company, is excited to announce its collaboration with AbleGamers for an impactful charity campaign at TwitchCon 2024. This partnership aims to further AbleGamers' mission of improving accessibility in gaming for individuals with disabilities through an interactive and meaningful activation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240919722398/en/ (Graphic: Xsolla) Attendees who visit the Xsolla booth (Booth 1515-SW) at TwitchCon will have the exclusive opportunity to claim one of two specially designed charity pins. By sharing a photo of their pin on their social channels on Instagram, Facebook, or Twitter using the hashtags #LightstreamAble and #XsollaAble, participants will help raise funds for AbleGamers. For every qualifying social post, Xsolla and its partners will donate $5 to AbleGamers

Sandvine Announces New Ownership and Capital Infusion19.9.2024 18:38:00 CEST | Press release

New ownership group commits new financingWill help to support reorientation of business and continued customer service and technological innovation Sandvine (the “Company”), a market-leading provider of Over-the-Top (OTT) Application Classification and Quality of Experience (QoE) solutions, today announced that it has been acquired by a group of leading US investment firms that previously were, and continue to be, lenders to the Company. In connection with this change of control transaction, the lenders agreed to reduce the Company’s total outstanding debt significantly. Following the change of control transaction, on September 13, 2024, these investors also entered into a binding agreement to provide new capital to Sandvine. The financing is expected to close in September 2024 and will strengthen the Company’s balance sheet. These enhancements to Sandvine’s financial position accompany its recently announced reorientation of its business model to focus on serving customers in large de

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
HiddenA line styled icon from Orion Icon Library.Eye