Travere Therapeutics, Inc., (TVTX) is approaching a key regulatory milestone as the U.S. FDA evaluates the company's supplemental New Drug Application for FILSPARI in focal segmental glomerulosclerosis. The agency in January 2026 extended its review, assigning a new PDUFA target action date of April 13, 2026.
If approved FILSPARI would become the first FDA-approved therapy for FSGS, a rare, progressive kidney disorder characterized by progressive scarring of the kidney, persistent proteinuria, and a high risk of progression to end-stage kidney disease. The condition affects an estimated 40,000 patients in the United States, with a similar prevalence in Europe.
Subscribe to continue reading the article.
This article is part of our premium content offering.Subscribe with a RTTNews subscription.
Subscribe NowAlready subscribed? Sign in
For comments and feedback: editorial@rttnews.com