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German Federal Joint Committee recognises “proof of a considerable additional benefit” for DIFICLIR for the treatment of CDI

Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare acquired infections[1]

Astellas Pharma Europe Ltd. announced today that the Federal Joint Committee (G-BA) of Germany has recognised a “proof of a considerable additional benefit” for DIFICLIR (fidaxomicin) in patients with severe and/or recurrent Clostridium difficile infection (CDI) in comparison to therapy with vancomycin, the current standard of care for these types of CDI.

CDI is one of the most common causes of healthcare-associated diarrhoea.[1] Hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[2],[3]Severe cases can lead to bowel surgery and even death.[1] CDI has an enormous impact on healthcare systems and infected patients can stay in hospital an extra 1-3 weeks[4],[5],[6],[7] at an additional cost of up to EUR14,000, compared with patients without CDI.[8]

“We welcome the G-BA’s recognition of DIFICLIR as a significant step towards improving the standard of care for patients with CDI,” said Ken Jones, President and CEO of Astellas Pharma Europe Ltd. “Until DIFICLIR, the treatment for CDI had remained largely unchanged for 20 years. With DIFICLIR we have a real treatment advance that can improve patient outcomes and reduce the significant burden of this disease.”

DIFICLIR received European marketing authorisation in December 2011[9] and was launched in Germany in January 2013.[10] The EU approval was based on two Phase III clinical studies comparing the efficacy and safety of 400mg/day oral DIFICLIR with 500mg/day oral vancomycin for a treatment period of 10 days in adults with CDI.[11],[12]

The proportion of subjects in whom clinical cure was achieved was similar for the two treatments, hence DIFICLIR met its primary endpoint of non-inferiority to vancomycin.[11],[12] In addition, DIFICLIR was shown to significantly reduce the rate of CDI recurrence as compared with vancomycin, which means that patients treated with DIFICLIR were significantly more likely than those receiving vancomycin to experience diarrhoea resolution without recurrence within 30 days of therapy completion.[11],[12]

Recurrence has been identified by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as being the most important problem in the treatment of DI.[13] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with vancomycin or metronidazole.[11],[14],[15]

“Patients with serious underlying conditions such as chronic kidney disease, cancer, or who are immunocompromised are at increased risk of serious complications associated with CDI,” comments Professor Cornely, University of Cologne, Germany. “With DIFICLIR we have a treatment that can reduce the risk of further episodes in these patients providing a key step towards improving the management of CDI and also to reducing the morbidity associated with the disease.”

The Gemeinsame Bundesausschuss (G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany.

The G-BA assesses any additional benefit claimed by newly authorised pharmaceuticals over the appropriate comparator within six months of the product launch. Since 2011, G-BA findings have formed the basis for price negotiations between statutory health insurance providers and the pharmaceutical industry for new active ingredients.

About Clostridium difficile Infection (CDI)

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.[16] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.[16],[17] The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.[18]


DIFICLIR, known as DIFICID(TM) in the US, was discovered and developed by Optimer Pharmaceuticals, Inc. It was approved by the US Food and Drug Administration in May 2011[19] and received European marketing authorisation in December[9] for the treatment of adults with CDI, also known as C. difficile-associated diarrhoea (CDAD).[9] Astellas Pharma Europe Ltd. is the exclusive licensee for the development and commercialisation of DIFICLIR in Europe and additional countries in the Middle East, Africa and the Commonwealth of Independent States.


1. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.

2. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.

3. Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect Dis. 2013;56:1108-16.

4. Vonberg RP, et al. Costs of nosocomial Clostridium difficile-associated diarrhoea. J Hosp Infect. 2008;70:15-20.

5. Wilcox MH, et al. Financial burden of hospital-acquired Clostridium difficile infection. J Hosp Infect. 1996;34:23-30.

6. Dubberke MD, Wertheimer AI. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009;30:57-66.

7. Eckmann C, et al. Increased hospital length of stay attributable to Clostridium difficile infection in patients with four co-morbidities: an analysis of hospital episode statistics in four European countries. Eur J Health Econ. 2013 Jun 25 [Epub ahead of print]

8. Magalini S, et al. An economic evaluation of Clostridium difficile infection management in an Italian hospital environment. Eur Rev Med Pharmacol Sci. 2012;16:2136-41.

9. European Commission. Community register of medicinal products for human use. Last accessed July 2013.

10. Gemeinsamer Bundesausschuss. Nutzenbewertungsverfahren zum Wirkstoff Fidaxomicin. Accessed July 2013.

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

12. Cornely OA, et al. 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;12:281-9.

13. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Microbiol Infect. 2009;15:1067-79.

14. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.

15. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl JMed. 2010;362:197-205.

16. Poutanen, SM et al. Clostridium difficile-associated diarrhoea in adults. CMAJ. 2004;171:51-8.

17. Kelly CP, et al. Clostridium difficile infection. Ann Rev Med. 1998;49:375-390.

18. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis. 2005;40:1591-7.

19. Food and Drug Administration. FDA approves treatment for Clostridium difficile infection [Internet]. [updated May 27 2011] Last accessed July 2013.

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