Five Prime Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for FPA008 for the treatment of Pigmented Villonodular Synovitis (PVNS), a locally aggressive tumor of the synovium.
"PVNS is a painful joint disease for which there are no currently approved treatments," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "FPA008 is our investigational antibody that we believe blocks the activation and survival of the macrophages that make up the bulk of the PVNS tumor. This orphan drug designation by the FDA highlights the need for new treatments to help patients with this rare disease."
Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to products that treat rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
