FDA accepts Optimer's fidaxomicin NDA for filing

Jan 24 2011

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for reducing the risk of recurrence when used for treatment of initial CDI. The FDA has also granted the Company's request for six-month Priority Review, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Additionally, the FDA has informed us that it plans to discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee currently scheduled for April 5, 2011.

The acceptance of the fidaxomicin NDA for filing confirms the FDA's determination that the NDA is sufficiently complete to permit a substantive review.  A Priority Review classification is granted to drugs that, if approved, have the potential to provide significant improvements compared to marketed treatments, or provide a treatment where no satisfactory alternative therapy exists. A Priority Review means that the goal for the time it takes the FDA to review a new drug application is reduced. Based on this classification, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011 for its review of the NDA.

"In Phase 3 clinical trials, fidaxomicin not only showed a high clinical cure rate, but also demonstrated a statistically significant improvement in reducing recurrences, one of the major problems in the current management of CDI," said Pedro Lichtinger, Optimer's President and CEO.  "The agency's acceptance of our NDA represents a step forward to fulfill an unmet medical need and supports our goal of helping patients who are suffering from this disease." 

The NDA is supported by data from the two largest comparative Phase 3 clinical trials ever conducted against vancomycin in CDI. The two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult patients. Patients with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatment of CDI. In both of these studies, fidaxomicin met the primary endpoint of non-inferiority of clinical cure compared to Vancocin. Importantly, in both trials fidaxomicin was statistically superior to Vancocin in reducing recurrences of CDI and in global cure rate.

SOURCE Optimer Pharmaceuticals, Inc.