FDA accepts NDA for fidaxomicin, a treatment for Clostridium difficile infection (CDI)
Optimer Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) submitted for fidaxomicin for the treatment of Clostridium difficile infection (CDI). This submission is supported by data from two fidaxomicin Phase 3 clinical studies. These studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult patients.
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile.
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