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

RHEINFELDEN, Switzerland – (COMMERCIAL THREAD) – Tillotts Pharma AG (“Tillotts”), part of the Japanese group Zeria, welcomes the recommendation that DIFICLIRMT (fidaxomicin) should be used for the initial treatment and the first recurrence of Clostridioides difficile infection (CDI) in the updated guidelines of the European Society for Clinical Microbiology and Infectious Diseases (ESCMID).1 The ESCMID guidelines now conform to the Infectious Disease Society of America (IDSA) guidelines which also recommend fidaxomicin for initial and recurrent episodes of CDI.1.2

In a clinical trial, the clinical cure rates with fidaxomicin were non-inferior to those with vancomycin (88.2% with fidaxomycin and 85.8% with vancomycin).3 Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of infection (15.4% vs 25.3%, P = 0.005).3 The non-inferiority of clinical cure was also demonstrated in a separate trial (87.7% with fidaxomicin and 86.8% with vancomycin).4 In this trial, similar results 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 with vancomycin ( 90.2% with fidaxomicin and 73.3% with vancomycin, P = 0.031).4

Healthcare-associated CDI infections are a burden on acute care hospitals in Europe with around 125,000 cases estimated each year.5 CDI frequently causes infectious diarrhea associated with healthcare and is associated with considerable morbidity, mortality and financial burden.6 Recurrence of the disease is a significant problem, with 20-30% of patients experiencing a recurring episode after the CDI initially resolves.7

“This recognition of the important role that DIFICLIRMT can play to help reduce the recurrence rate is good news for patients and clinicians across Europe, ”said Adrian Hill, head of international operations, Tillotts Pharma. “Fidaxomicin is not only effective in the treatment of CDI, it also reduces recurrence, which impacts the lives of patients and costs healthcare systems millions of dollars each year.

“This new ESCMID directive is welcome, and in particular brings Europe into compliance with recent American directives (IDSA) ”, comments Professor Mark Wilcox, MD, consultant and member of the group and co-author of the directive. ESCMID treatment CDI and professor of medical microbiology. , Leeds University Hospitals and Leeds University, UK. “This provides clarity for clinicians, allowing best practice adoption at a steady pace. Despite the endemic nature of It’s hard in many healthcare settings, sustained clinical healing and prevention of recurrence are achievable treatment goals for CDI.

Fidaxomicin treats CDI with minimal disruption of the microbiota, helping to preserve resistance to colonization and limiting opportunities for It’s hard recurrence.3

ENDS

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

Job code: PM-DIF-ALL-00030

Date of preparation: November 2021

The references

  1. Van Prehn J et al. European Society for Clinical Microbiology and Infectious Diseases: 2021 Update on 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. Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) Clinical Practice Guidelines: 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 Clostridium difficile infection in Europe, Canada and the United States: a randomized, double-blind, non-inferiority controlled trial. Lancet Infect Dis. 2012 Apr; 12 (4): 281-9. doi: 10.1016 / S1473-3099 (11) 70374-7. Published online February 8, 2012. PMID: 22321770.

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

  6. Tresman R and Goldenberg SD. Health resource use and attributable cost of Clostridium difficile infection: a microscopic cost analysis comparing early episodes 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 DIFICLIRMT

DIFFICULTMT is a macrocyclic antibacterial agent. It is presented as film-coated tablets for oral administration. The tablets are indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile associated diarrhea (CDAD) in adult and pediatric patients weighing 12.5 kg or more. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. DIFFICULTMT works by inhibiting the bacterial enzyme RNA polymerase, resulting in the rapid death of C. difficile. It selectively eradicates C. difficile with minimal disruption of normal gut flora.

About Tillotts

Tillotts Pharma AG, part of the Japanese Zeria Group, is a growing specialty pharmaceutical company with more than 300 employees in Switzerland and abroad. Tillotts is dedicated to the development, acquisition and commercialization of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD and Clostridioides difficile infections (CDI) as well as licensed products in approximately 65 countries through its subsidiaries in Europe and a network of specialist partners in the area of ​​infection. gastroenterology around 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 the R&D, manufacture and sale of prescription drugs as well as OTC products. The company is listed on the First Section of the Tokyo Stock Exchange (stock code: 4559). Zeria occupies a leading position in the field of gastroenterology in Japan and operates internationally through a number of subsidiaries. For more information on Zeria, please visit www.zeria.co.jp

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