Tillotts Pharma AG announces that DIFICLIRTM (Fidaxomicin) is recommended by ESCMID for the treatment of Clostridioides difficile infections (CDI)

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RHEINFELDEN, Switzerland –



Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, welcomes the recommendation that DIFICLIRTM (Fidaxomicin) as an initial treatment and treatment of the first relapse of Clostridioides difficileInfections should be applied. The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) made this recommendation as part of an updated guideline.1 The ESCMID guideline is now in line with the guidelines of the IDSA (Infectious Disease Society of America), which also recommend fidaxomicin as an initial treatment and treatment of relapses in CDI.1.2

In a clinical study, the rate of clinical cure with fidaxomicin was not inferior to that achieved with vancomycin (88.2% with fidaxomicin and 85.8% with vancomycin).3 Significantly fewer patients in the fidaxomicin group compared to the vancomycin group had a recurrence of the infection (15.4% vs. 25.3%, P = 0.005).3 Non-inferiority in terms of clinical cure was also demonstrated in a separate study (87.7% with fidaxomicin vs. 86.8% with vancomycin).4th In this study, similar outcomes were found in the modified intention-to-treat treatment groups. However, patients receiving antibiotics for other infections concomitantly had a higher cure rate with fidaxomicin than with vancomycin (90.2% with fidaxomicin vs. 73.3% with vancomycin, P = 0.031).4th

With an estimated 125,000 cases per year, nosocomial (healthcare-associated) CDI infections represent a burden for acute hospitals in Europe.5 CDI often causes nosocominal diarrheal disease and is associated with considerable morbidity, mortality, and financial burden.6th Disease recurrence is an important problem because 20–30% of patients experience a recurrence of CDI after the infection has initially resolved.7th

“This confirmation of the important role played by DIFICLIRTM can play in reducing relapse rates is good news for patients and clinicians across Europe, ”said Adrian Hill, Head of International Operations, Tillotts Pharma. “Fidaxomicin is not only effective as a treatment for CDI, it also reduces the incidence of relapses. Such relapses affect patients’ quality of life and cost healthcare systems millions of euros every year. ”

“This new ESCMID guideline is welcome and brings Europe in line with the most recent US (IDSA) guideline,” commented Professor Mark Wilcox, MD, Consultant, and Group Member and Co-Author of ESCMID’s CDI Therapy Guideline and Professor of Medical Microbiology the Leeds Teaching Hospitals and the University of Leeds (UK). “This gives doctors clarity and enables them to quickly adopt best practices. Even if C. difficile is endemic in many places in the health care system, sustained clinical cure and prevention of relapse are achievable treatment goals in CDI. ”

When treating CDI with fidaxomicin, the intestinal flora is only minimally affected. This will help maintain colonization resistance and the possibility of it becoming one C. difficile-Recurrence is coming, restrict.3

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Tillotts Pharma AG – Baslerstrasse 15 – 4310 Rheinfelden – Switzerland – Tel .: +41 61 935 2626 – www.tillotts.com

Job code: PM-DIF-ALL-00030

Date of creation: November 2021

References

  1. Van Prehn J et al. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. Clinical Microbiology and Infection, 2021. https://doi.org/10.1016/j.cmi.2021.09.038.

  2. Johnson S et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clin Infect Dis 2021; 73 (5): e1029-44.

  3. Louie TJ et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011; 364: 422-31.

  4. Cornely OA, Crook DW, Esposito R, Poirier A, Somero MS, Weiss K, Sears P, Gorbach S; OPT-80-004 Clinical Study Group. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomized controlled trial. Lancet Infect Dis. 2012 Apr; 12 (4): 281-9. doi: 10.1016 / S1473-3099 (11) 70374-7. Epub 2012 Feb 8. PMID: 22321770.

  5. European Center for Disease Prevention and Control (ECDC). Clostridium difficile infections – Facts and surveillance. https://www.ecdc.europa.eu/en/clostridium-difficile-infections/facts. Retrieved October 2021

  6. Tresman R and Goldenberg SD. Healthcare resource use and attributable cost of Clostridium difficile infection: a micro-costing analysis comparing first and recurrent episodes. J Antimicrob Chemother 2018; 73: 2851-2855.

  7. Deshpande A, Pasupuleti V, Thota P et al (2015) Risk factors for recurrent Clostridium difficile infection: a systematic review and meta-analysis. Infect Control Hosp Epidemiol 36: 452-460 10.

About DIFICLIRTM

DIFICLIRTM is a macrocyclic antibiotic. It is available in the form of film-coated tablets for oral administration. The tablets are indicated in adults for the treatment of Clostridium difficile infections (CDI), also known as Clostridium difficile-associated diarrhea (CDAD), and in children weighing at least 12.5 kg. Official guidelines on the appropriate use of antibiotics should be considered. DIFICLIRTM acts by inhibiting the bacterial enzyme RNA polymerase, which quickly kills Clostridium difficile. It selectively eliminates Clostridium difficile with minimal disruption to normal intestinal flora.

About Tillotts

Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast growing, highly specialized pharmaceutical company with more than 300 employees in Switzerland and other locations around the world. Tillotts is involved in the development, in-licensing, out-licensing and marketing of innovative pharmaceutical products for the digestive tract. Tillotts successfully markets its own products for the treatment of inflammatory bowel disease as well as in-licensed products in more than 65 countries. It relies on its subsidiaries in Europe and a network of partners in the field of gastroenterology around the world.

All trademarks used or mentioned in this press release are protected by law. © Copyright Tillotts Pharma AG. All rights reserved.

For more information, see www.tillotts.com

About Zeria

Zeria Pharmaceutical Co., Ltd., founded in 1955 and based in Tokyo, Japan, focuses on the research and development, manufacture and sale of prescription drugs and OTC products. The company is listed on the first section of the Tokyo Stock Exchange (symbol: 4559). Zeria occupies a leading position in the field of gastroenterology in Japan and operates internationally through various subsidiaries. You can find more information about Zeria at www.zeria.co.jp

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Source: Business Wire

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