Optimer gets the NDA rolling for C. Diff therapy fidaxomicin
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryOptimer Pharmaceuticals announced Sept. 22 that it has submitted the first section of a rolling NDA for its macrocyclic antibiotic fidaxomicin to treat patients with Clostridium difficile and to prevent recurrences. Relapse is a major concern with the opportunistic disease of hospitalized patients whose intestinal flora are thrown out of balance by broad-spectrum antibiotics aimed at other bacteria. Optimer plans to complete the submission in the fourth quarter and to request priority review, which could lead to regulatory action in the second quarter of 2011. Fidaxomicin's narrow spectrum profile may eradicate C. diff selectively with minimal disruption to the normal intestinal flora, unlike the current standard of care off-label metronidazole and vancomycin, according to Optimer. Relapse rates with standard of care are 20% to 30%. Although Optimer has the lead new agent in the field, other companies are working on an answer to C. diff ( 1"Fighting C. Difficile: Beyond Optimer's Fidaxomicin," Pharmaceutical Approvals Monthly, February 2010)
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