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2021.12.08

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

  • DIFICLIRTM (fidaxomicin) is now recommended as first-line CDI treatment in both European and U.S. guidelines1,2
  • Significantly fewer patients in the fidaxomicin group than the vancomycin group had a recurrence of infection at four weeks3

 

RHEINFELDEN, Switzerland 08.12.2021 –Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, welcomes the recommendation that DIFICLIRTM (fidaxomicin) should be used for the initial treatment and first recurrence of Clostridioides difficile infection (CDI) in updated guidance from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).1 ESCMID guidance is now consistent with the Infectious Disease Society of America (IDSA) guidelines which also recommend fidaxomicin for initial and recurrent episodes of CDI.1,2

 

In one clinical trial, the rates of clinical cure with fidaxomicin were noninferior to those with vancomycin (88.2% with fidaxomicin and 85.8% with vancomycin).3 Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection (15.4% vs. 25.3%, P=0.005).3 Clinical cure noninferiority was also demonstrated in a separate trial (87.7% with fidaxomicin and 86.8% with vancomycin).4 In this trial similar outcomes were seen in the modified intention-to-treat treatment groups, although patients receiving concomitant antibiotics for other infections had a higher cure rate with fidaxomicin than vancomycin (90.2% with fidaxomicin and 73.3% with vancomycin, P=0.031).4

 

Healthcare-associated CDI infections represent a burden to acute care hospitals in Europe with around 125,000 cases estimated annually.5 CDI frequently causes healthcare-associated infectious diarrhoea and is associated with considerable morbidity, mortality and financial burden.6 Recurrence of disease is a significant problem, with 20–30% of patients experiencing a recurrent episode following initial resolution of CDI.7

 

“This recognition of the important role that DIFICLIRTM can play in helping to reduce the rate of recurrence is good news for patients and clinicians across Europe,” says Adrian Hill, Head of International Operations, Tillotts Pharma. “Fidaxomicin is not only effective for the treatment of CDI, it also reduces recurrence, something which impacts the lives of patients and costs health systems millions of euros every year.”

“This new guideline from ESCMID is welcome, and notably brings Europe into line with recent U.S. (IDSA) guidance,” comments Professor Mark Wilcox, MD, Consultant, and group member and co-author of the ESCMID CDI treatment guideline and Professor in Medical Microbiology, at Leeds Teaching Hospitals & University of Leeds, UK. “This provides clinicians with clarity, allowing best practice to be adopted at pace. Despite the endemic nature of C. difficile in many healthcare settings, sustained clinical cure and prevention of recurrence are achievable treatment goals for CDI.”

Fidaxomicin treats CDI with minimal disruption to the microbiota, helping to preserve colonisation resistance and restricting opportunities for C. difficile recurrence.3

For more information, contact:

Tillotts Pharma AG
Susi Teichmann
Senior Manager Corporate Communications
Phone: +41 61 9352 759
Email: Susi.Teichmann@tillotts.com

 

 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, randomised 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 Centre for Disease Prevention and Control (ECDC). Clostridium difficile infections – Facts and surveillance. https://www.ecdc.europa.eu/en/clostridium-difficile-infections/facts. Accessed 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 anti-bacterial agent. It is formulated as film-coated tablets for oral route of administration. The tablets are indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. DIFICLIRTM acts by inhibiting the bacterial enzyme RNA polymerase, resulting in rapid killing of C. difficile. It eradicates C. difficile selectively with minimal disruption to the normal intestinal flora.

 

About Tillotts

Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with over 300 employees in Switzerland and abroad. Tillotts is dedicated to the development, acquisition and commercialisation of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD and Clostridoides difficile infection (CDI) as well as in-licensed products in around 65 countries through its affiliates within Europe and a network of gastroenterology-focused partners throughout the world.

All trademarks used or mentioned here are protected by law. © Copyright Tillotts Pharma AG. All rights reserved.

For more information, please visit www.tillotts.com

 

About Zeria

Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, focuses on R&D, manufacturing and sales of prescription drugs as well as OTC products. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559). Zeria holds a leading position within the gastroenterology field in Japan and operates internationally through a number of subsidiaries. For more information about Zeria, please visit www.zeria.co.jp

 

Download high-resolution photos here

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  • DIFICLIRTM (fidaxomicin) is now recommended as first-line CDI treatment in both European and U.S. guidelines1,2
  • Significantly fewer patients in the fidaxomicin group than the vancomycin group had a recurrence of infection at four weeks3
  RHEINFELDEN, Switzerland 08.12.2021 –Tillotts Pharma AG (“Tillotts”), part of the Japanese Zeria Group, welcomes the recommendation that DIFICLIRTM (fidaxomicin) should be used for the initial treatment and first recurrence of Clostridioides difficile infection (CDI) in updated guidance from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).1 ESCMID guidance is now consistent with the Infectious Disease Society of America (IDSA) guidelines which also recommend fidaxomicin for initial and recurrent episodes of CDI.1,2   In one clinical trial, the rates of clinical cure with fidaxomicin were noninferior to those with vancomycin (88.2% with fidaxomicin and 85.8% with vancomycin).3 Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection (15.4% vs. 25.3%, P=0.005).3 Clinical cure noninferiority was also demonstrated in a separate trial (87.7% with fidaxomicin and 86.8% with vancomycin).4 In this trial similar outcomes were seen in the modified intention-to-treat treatment groups, although patients receiving concomitant antibiotics for other infections had a higher cure rate with fidaxomicin than vancomycin (90.2% with fidaxomicin and 73.3% with vancomycin, P=0.031).4   Healthcare-associated CDI infections represent a burden to acute care hospitals in Europe with around 125,000 cases estimated annually.5 CDI frequently causes healthcare-associated infectious diarrhoea and is associated with considerable morbidity, mortality and financial burden.6 Recurrence of disease is a significant problem, with 20–30% of patients experiencing a recurrent episode following initial resolution of CDI.7   “This recognition of the important role that DIFICLIRTM can play in helping to reduce the rate of recurrence is good news for patients and clinicians across Europe,” says Adrian Hill, Head of International Operations, Tillotts Pharma. “Fidaxomicin is not only effective for the treatment of CDI, it also reduces recurrence, something which impacts the lives of patients and costs health systems millions of euros every year.” “This new guideline from ESCMID is welcome, and notably brings Europe into line with recent U.S. (IDSA) guidance,” comments Professor Mark Wilcox, MD, Consultant, and group member and co-author of the ESCMID CDI treatment guideline and Professor in Medical Microbiology, at Leeds Teaching Hospitals & University of Leeds, UK. “This provides clinicians with clarity, allowing best practice to be adopted at pace. Despite the endemic nature of C. difficile in many healthcare settings, sustained clinical cure and prevention of recurrence are achievable treatment goals for CDI.” Fidaxomicin treats CDI with minimal disruption to the microbiota, helping to preserve colonisation resistance and restricting opportunities for C. difficile recurrence.3 For more information, contact: Tillotts Pharma AG Susi Teichmann Senior Manager Corporate Communications Phone: +41 61 9352 759 Email: Susi.Teichmann@tillotts.com    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, randomised 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 Centre for Disease Prevention and Control (ECDC). Clostridium difficile infections – Facts and surveillance. https://www.ecdc.europa.eu/en/clostridium-difficile-infections/facts. Accessed 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.
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