FDA Approves Filspari for Rare Kidney Disease IgA Nephropathy
- By BSTQ Staff
The U.S. 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).
Filspari, which was approved under FDA’s accelerated approvals pathway in February 2023 for primary IgAN patients who are at risk of rapid disease progression, is an oral, once-daily non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression.
FDA’s latest approval expands the drug’s indication to cover all patients who are at risk of disease progression and was supported by positive long-term confirmatory results from the Phase III PROTECT study in which Filspari significantly slowed kidney function decline over two years compared to irbesartan.
The positive treatment effects on proteinuria (protein in the urine) that were observed at week 36 were durable out to the two-year measurement period, and results showed that Filspari was well-tolerated with a “clearly defined” safety profile consistent across all clinical trials conducted to date.
References
- Kimber, E. FDA Grants Full Approval to Travere’s Filspari for Rare Kidney Disease IgA Nephropathy. PMLive, Sept. 9, 2024. Accessed at pmlive.com/pharma_news/fda-grants-full-approval-to-traveres-filspari-for-rare-kidney-disease-iga-nephropathy.
