The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for sparsentan for the treatment of immunoglobulin A (IgA) nephropathy.
IgA nephropathy (IgAN) is a rare disease characterized by the accumulation of IgA in the kidneys, which causes cellular changes within the glomeruli and damages the glomerular filtration barrier. Sparsentan is designed to selectively block the receptors of endothelin type A and angiotensin II type I, which are associated with kidney disease progression.
The NDA is supported by data from the randomized, double-blind, parallel-group, active-control phase 3 PROTECT study (ClinicalTrials.gov Identifier: NCT03762850), which evaluated the efficacy and safety of sparsentan, compared with irbesartan, in 404 adults with IgAN and persistent proteinuria despite available ACEI or ARB therapy. The primary endpoint was the change from baseline in the urine protein/creatinine ratio (UP/C) at week 36.
Results showed that the sparsentan group achieved a mean reduction in proteinuria of 49.8% vs 15.1% with irbesartan after 36 weeks of treatment (P <.0001). A preliminary review of the interim safety data indicated that sparsentan was generally well tolerated in the study.
“If approved, sparsentan would be the first FDA-approved non-immunosuppressive treatment option for IgA nephropathy, and we aspire to ultimately position sparsentan as a new standard of care,” said Eric Dube, PhD, president and chief executive officer of Travere Therapeutics. “Acceptance of the NDA and being granted Priority Review brings us one step closer to potentially delivering sparsentan to the IgA nephropathy community before the end of this year, and we look forward to continuing to work with the FDA throughout the review process.”
A Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2022 has been set for the application.
Travere Therapeutics announces FDA acceptance and Priority Review of New Drug Application for sparsentan for the treatment of IgA nephropathy. News release. Travere Therapeutics, Inc. Accessed May 16, 2022. https://www.globenewswire.com/news-release/2022/05/16/2443695/0/en/Travere-Therapeutics-Announces-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Sparsentan-for-the-Treatment-of-IgA-Nephropathy.html