Optimer to file fidaxomicin after second positive Phase III study
This article was originally published in Scrip
Executive Summary
Optimer Pharmaceuticals' narrow-spectrum antibiotic fidaxomicin has met the non-inferiority primary endpoint of its second Phase III study for the treatment of Clostridium difficile infections.
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Optimer's fidaxomicin filing accepted in EU
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI.