NEWS European Commission Grants Marketing Authorization for fidaxomicin
Optimer Pharma and Astellas Pharma Europe announced that the European Commission has granted Marketing Authorization for DIFICLIR tablets for the treatment of adults with Clostridium difficile infection.
Astellas Pharma Europe Ltd. is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and additional countries in the Middle East , Africa and the Commonwealth of Independent States.
Phase 3 clinical trials that demonstrated that DIFICLIR was as effective as oral vancomycin in treating CDI. DIFICLIR had a significantly lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment. DIFICLIR is the only drug approved by the EMA proven to significantly lower the rate of recurrence of CDI compared to oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.