Dificlir Wins European Marketing Authorisation
The approval was based on two multi-national Phase III clinical trials, which demonstrated that Dificlir is as effective as oral vancomycin in treating CDI.
The European Commission has granted marketing authorisation for Dificlir (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI).
The approval was based on two multi-national Phase III clinical trials, which demonstrated that Dificlir is as effective as oral vancomycin in treating CDI. Dificlir had a significantly lower rate of recurrence (including relapses) compared with vancomycin in the 30 days following treatment. Dificlir is the only drug approved by the EMA that is proven significantly to lower the rate of recurrence of CDI compared with oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.
The European approval affirms the recent positive opini
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