GenVec, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TNFerade(TM) for the treatment of pancreatic cancer.
The FDA grants orphan drug designation to drugs that may provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation provides potential financial and regulatory incentives including study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval.
"Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits," stated Dr. Paul Fischer, GenVec's President and CEO.