Dificlir (fidaxomicin) from Astellas Pharma, available in tablet form, specifically targets C. difficile bacteria and is more effective in preventing recurrence of the infection than the standard therapy.
The drug, a macrocyclic antibiotic, was developed by US company Optimer Pharmaceuticals and is licensed exclusively to Astellas in Europe.
C. difficile infection (CDI) typically develops in patients where the use of broad-spectrum antibiotics has suppressed the normal intestinal flora. It results in long hospital stays and risk of death.
Despite hygiene measures, C. difficile remains a significant problem in long-term care facilities, with high (25%) rates of recurrence in patients treated with current therapies.
The EC approval of Dificlir followed two phase III clinical studies in Europe and North America, comparing the efficacy and safety of Dificlir with vancomycin (the standard CDI treatment) over 10 days.
While Dificlir achieved the same rate of clinical cure as vancomycin, it was significantly more effective in reducing CDI recurrence and had less negative impact on the normal intestinal flora and on general health.
“The high rate of disease recurrence is the greatest limitation of current treatments for CDI,” said Mark Wilcox, Professor of Medical Microbiology at Leeds Teaching Hospitals. “The significant reduction in disease recurrence by Dificlir compared with vancomycin is a key step to reducing the morbidity associated with CDI, and this new treatment option is a welcome addition that has the potential to improve the patient experience.”
Ken Jones, President and CEO of Astellas Pharma Europe, commented: “Treatment for CDI has changed little in the past 20 years. The EU approval of Dificlir is therefore an important advance.”