Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Sep 21 2010

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

"With our NDA submission underway, we continue on the path of bringing this much needed therapy to CDI patients," said Pedro Lichtinger, President and CEO of Optimer. "CDI is a serious health threat and the incidence of the infection continues to increase. We believe fidaxomicin may become the best therapeutic option for this critical illness and we look forward to its commercialization, if approved."

Fidaxomicin received Fast Track designation from the FDA in 2003 for the treatment of CDI. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The rolling submission process enables companies that have been granted Fast Track designation by the FDA to submit completed sections of its NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.