MOUNTAIN VIEW, California, June 8, 2011 /PRNewswire/ --
- Designation covers inherited respiratory chain diseases of the mitochondria
Edison Pharmaceuticals, Inc. announced today the United States Food and Drug Administration has granted orphan drug designation to EPI-743 for treatment of inherited mitochondrial respiratory chain diseases. Today, these mitochondrial diseases affect an estimated 60,000 individuals.
The Orphan Drug Act, passed in 1982, provides incentives for companies to pursue treatments for diseases affecting fewer than 200,000 individuals in the United States. Such designation provides an accelerated review and a seven-year period of exclusivity upon FDA approval.
The FDA granted orphan drug designation to Edison's EPI-743 based on review of the application, which included clinical and pre-clinical data demonstrating a favorable efficacy and safety profile.