Sparsentan Receives Full FDA Approval for Treatment of IgAN

The US Food and Drug Administration (FDA) has granted full approval to Travere Therapeutics’ FILSPARI (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. Sparsentan is the only oral, once-daily, nonimmunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II).

The drug received accelerated approval from the FDA in February 2023 based on the surrogate marker of proteinuria reduction. The full approval was based on long-term confirmatory results from the PROTECT study, showing that sparsentan significantly slowed kidney function decline over 2 years compared with irbesartan.

“This approval should facilitate patient access to a medication that targets injury directly in the kidney, reduces proteinuria, even to the point of complete remission in some patients, and is more effective than current standard-of-care treatment in preserving kidney function over time. This is a very exciting milestone in the evolution of treating IgAN,” said Brad Rovin, MD, of The Ohio State University Wexner Medical Center, a steering committee member for PROTECT.