Travere (TVTX.US) "first-in-class" therapy receives full FDA approval, significantly slows kidney function decline

Travere Therapeutics(TVTX.US) announced on September 7 that the U.S. FDA has fully approved Filspari (sparsentan), a "first-in-class" therapy, for slowing the decline in kidney function in adult patients with primary IgA nephropathy (IgAN) who are at risk of disease progression. Filspari received accelerated approval in February 2023 based on urinary protein biomarkers. The full approval was based on positive long-term confirmatory results from the PROTECT study, which showed that Filspari significantly slowed the decline in kidney function over two years compared to the active comparator drug irbesartan.