Dificlir (fidaxomicin), which gained EC approval in December 2011, shows a lower rate of recurrence and better sustained response than vancomycin, the current standard of care.
The new treatment has potential to address the growing problem of recurrent and persistent CDI in hospitals and care homes.
Recurrence of CDI occurs in up to 25% of patients within a month of treatment and is the most serious problem in treatment of the disease, according to the European Society of Clinical Microbiology and Infectious Diseases.
In the phase III trial Study OPT-80-004, 5089 adults with CDI in seven European countries and North America received oral Dificlir or oral vancomycin for 10 days.
The results over 30 days showed that Dificlir achieved a lower level of CDI recurrence (12.7% versus 26.9%) and a better level of sustained response or clinical cure without recurrence (76.6% versus 63.4%) than vancomycin.
Professor Oliver Cornely, Medical Director of the Clinical Trial Centre at the University of Cologne, Germany, said: “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.
“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.”
Ken Jones, President and CEO of Astellas Pharma Europe, said: “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.”
Dificlir, first developed by Optimer Pharmaceuticals, is exclusively licensed to Astellas Pharma Europe for development and commercialisation in Europe.
UK-based Astellas Pharma Europe Ltd is a European subsidiary of Tokyo-based company Astellas Pharma Inc.