Optimer Pharmaceuticals, Inc. announced that it has completed the submission of its 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. It is the most common cause of diarrhea in the hospital, and according to the CDC contributes to 15,000-30,000 deaths each year, a number that surpasses Methicillin-resistant Staphylococcus aureus (MRSA).
“This NDA filing is one of the most significant achievements in the history of Optimer,” said Pedro Lichtinger, President and CEO of Optimer. “This submission is the culmination of many years of dedicated work by the Optimer team, as well as the efforts of our clinical trial investigators and advisors to bring this much needed therapy to CDI patients. We believe fidaxomicin represents a major advance in CDI treatment, and every step we move closer to the possibility of it reaching patients is meaningful to those who are impacted by the disease.”
Optimer has also requested priority review, which if granted could lead to an approval decision from the FDA in the second quarter of 2011. Fidaxomicin received Fast Track designation from the FDA in 2003 for the treatment of CDI, which allowed the Company to initiate a rolling NDA submission.
In August 2010, the Company’s Marketing Authorization Application (MAA) filing for fidaxomicin was accepted for review by the European Medicines Agency.
Date: December 1, 2010
Source: Optimer Pharmaceuticals, Inc.
