FDA grants Priority Review for sNDA to convert FILSPARI® from accelerated approval to full approval for the treatment of IgAN in the U.S.; PDUFA target action date of September 5, 2024 Received 511.
First non-immunosuppressive therapy for the treatment of IgA nephropathy approved in Europe Conditional marketing authorization is based on statistically significant and clinically meaningful.
Upcoming data presentations underscore the potential for FILSPARI to become a foundational treatment for IgAN and Travere’s leadership and commitment to innovation in rare kidney disease SAN DIEGO,.
Submission is based on 2-year confirmatory results from the Phase 3 PROTECT Study in which FILSPARI demonstrated a significant reduction in proteinuria, preservation of kidney function and a generally.