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news.Optimer Pharmaceuticals and Astellas Pharma Europe announced the European Commission has granted Marketing Authorization (MA) for Dificlir (fidaxomicin) tablets to treat Clostridium difficile infections (CDI), also known as Clostridium difficile-associated diarrhea (CDAD).
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The move of the European agency is backed by two large, multi-national, Phase 3 clinical trials that demonstrated the efficacy of Dificlir as oral vancomycin to treat CDI.
Dificlir showed a lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment.
Optimer president and CEO Pedro Lichtinger said the approval would help expand the availability of fidaxomicin to patients with CDI across the globe.
"We believe we have obtained a very strong label recognizing the benefits of Dificlir versus vancomycin, including significant reductions in recurrence," Lichtinger added.