Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)
The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
- The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
- “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
- “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
- The FDA has 60 days from the receipt of the application to determine whether to accept it for review.