Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to sparsentan for the treatment of IgA nephropathy (IgAN), a rare kidney disorder and a leading cause of end-stage kidney disease (ESKD). Sparsentan is an investigational product candidate currently being evaluated for the treatment of IgAN, as well as focal segmental glomerulosclerosis (FSGS) in pivotal Phase 3 clinical trials that are expected to report topline data from interim proteinuria assessments in 2021. The Orphan Drug Designation program is intended to encourage the development of therapeutics for diseases that affect fewer than 200,000 individuals in the United States. Prior to FDA approval, Orphan Drug Designation qualifies sponsors for certain incentives, such as tax credits toward the cost of clinical trials and prescription drug user fee waivers. Orphan Drug Designation may also convey seven years of marketing exclusivity for sparsentan if approved by the FDA for the treatment of IgAN. Travere Therapeutics previously received a positive opinion from the European Medicines Agency Committee for Orphan Medicinal Products on the company’s application for Orphan Drug Designation for IgAN in Europe, and it holds Orphan Drug Designation for sparsentan for the treatment of FSGS in the U.S. and Europe.