Study Published Today in The Lancet Infectious Diseases shows that DIFICLIR[TM] Offers Potential Benefits Over Current Standard of Care for Clostridium difficile Infection

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Astellas Pharma Europe Ltd

26 Mar, 2012, 07:30 GMT

STAINES, England, March 26, 2012 /PRNewswire/ --

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

Data published today in The Lancet Infectious Diseases, demonstrate that DIFICLIR (fidaxomicin) has a similar efficacy and tolerability profile to oral vancomycin, the current standard of care for CDI, but offers the benefit of a superior sustained response and a greater reduction in rates of recurrence.[1]  

CDI, which results from infection of the internal lining of the colon by C. difficile bacteria, is one of the most common healthcare-acquired infections in the European Union.[2] CDI is a significant problem in hospitals, nursing homes and other long-term care facilities.[3] Severe cases can require bowel surgery and even lead to death.[4] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.[5,6,7] The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has identified recurrence as being the most important problem in the treatment of CDI.[8]

In this multi-centre, double-blind, randomised, non-inferiority Phase III trial (known as Study OPT-80-004), 509 adults with CDI in seven European countries and North America received 400mg/day oral DIFICLIR or 500mg/day oral vancomycin for 10 days. The proportion of subjects in whom clinical cure* was achieved were similar for the two treatments meaning that DIFICLIR met the primary endpoint of non-inferiority to vancomycin. The results further show that DIFICLIR offers potential advantages over vancomycin in CDI recurrence and sustained response. The rate of CDI recurrence within 30 days after completion of therapy was significantly lower among those treated with DIFICLIR (12.7%) compared with those receiving vancomycin (26.9%, p<0.001). Also, DIFICLIR recipients were more likely than those treated with vancomycin to experience a sustained response (clinical cure without recurrence within 30 days of completing treatment) (76.6% vs. 63.4% respectively, p=0.001).[1]

"CDI is a significant and growing problem in hospitals and care homes. The high percentage of patients experiencing CDI recurrence remains one of the biggest barriers to improving the management of this severe and sometimes life-threatening condition", said Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne, Germany and lead investigator of the study. "In this study, DIFICLIR significantly reduced disease recurrence compared to vancomycin, the current standard of care, showing real promise as an effective treatment alternative for patients with CDI."

The trial reported in the Lancet Infectious Diseases was performed in centres in Belgium, France, Germany, Italy, Spain, Sweden and the United Kingdom, as well as North America. It is the second of two identically designed Phase III trials that compared DIFICLIR and vancomycin in patients with CDI. The other trial (Study OPT-80-003), which was conducted in the United States and Canada only, also showed that DIFICLIR was non-inferior to vancomycin in terms of clinical cure and associated with a significantly lower rate of CDI recurrence.[7]

"There is a clear need for new treatment advances to reduce the impact of this distressing and widespread disease. The results of this study reinforce the strong data we have already seen for DIFICLIR and support its position as a new and exciting treatment option for CDI," said Ken Jones, President and CEO of Astellas Pharma Europe Ltd.

DIFICLIR, known as DIFICID™ in the US, was discovered and developed by Optimer Pharmaceuticals, Inc. It was approved by the US Food and Drug Administration in May 2011[9] and received European marketing authorisation in December 2011 for the treatment of adults with CDI, also known as C. difficile-associated diarrhoea (CDAD).[10] 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.

*Please note: clinical cure was defined as the resolution of diarrhoea for the duration of treatment and no need for further CDI therapy two days after completion of study medication, as determined by the investigator.

NOTES TO EDITORS:

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.[11] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.[11] The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.[12] CDI results in substantial costs to healthcare systems, in particular because of extended hospitalisation.[13] Patients with CDI stay in hospital for approximately 3.6 days longer and have 54% higher adjusted hospital costs compared with those without CDI.[14]

About Astellas Pharma Europe

Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,200 staff across these regions. For more information about Astellas Pharma Europe, please visit www.astellas.eu .

References

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  2. European Centre for Disease Prevention and Control. http://ecdc.europa.eu/en/healthtopics/healthcare-associated_infections/pages/index.aspx. Last accessed January 2011.
  3. Simor AE, et al. Clostridium difficile in long-term-care facilities for the elderly. Infect Control Hosp Epidemiol. 2002;23:696-703.
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  10. European Commission. Community register of medicinal products for human use. http://ec.europa.eu/health/documents/community-register/html/h733.htm. Last accessed March 2012.  
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  14. Kyne L, et al. Health care costs and mortality associated with nosocomial diarrhea due to Clostridium difficile. Clin Infect Dis. 2002;1;34(3):346-53.