The European Commission has granted a marketing authorisation for fidaxomicin (DIFICLIR™) tablets for the treatment of adults with Clostridium difficile infections (CDI), also known as C. difficileassociated diarrhoea (CDAD), in the European Union. The EU authorisation of fidaxomicin was based on two phase III clinical studies comparing the efficacy and safety of 400mg/ day oral fidaxomicin with 500mg/ day oral vancomycin (the only authorised treatment for CDI) for a treatment period of 10 days in adults with CDI in Europe and North America. The proportion of subjects in whom clinical cure was achieved were similar for the two treatments, and hence fidaxomicin met the primary endpoint of non-inferiority to vancomycin. Furthermore, fidaxomicin significantly reduced the rate of CDI recurrence compared with vancomycin, with fidaxomicin treated patients significantly more likely than those receiving vancomycin to experience diarrhoea resolution without recurrence within 30 days of therapy completion. Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds, said: “The high rate of disease recurrence is the greatest limitation of current treatments for CDI. Te 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.”