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February 17, 2023Pozelimab (C5 Antibody) BLA for Treatment of Children and Adults
February 21, 2023February 17, 2023 - Travere Therapeutics, Inc. has announced that the U.S. Food and Drug Administration has granted accelerated approval to FilspariTM (sparsentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
This indication is granted under accelerated approval based on reduction in proteinuria. It has not been established whether Filspari slows kidney function decline in patients with IgAN. The continued approval of Filspari may be contingent upon confirmation of a clinical benefit in the ongoing Phase 3 PROTECT Study, which is designed to demonstrate whether Filspari slows kidney function decline.
Topline results from the two-year confirmatory endpoints in the PROTECT Study are expected in the fourth quarter of 2023 and are intended to support traditional approval of Filspari.
Filspari, a once-daily oral medication is designed to selectively target two critical pathways in the disease progression of IgAN (endothelin-1 and angiotensin II) and is the first and only non-immunosuppressive therapy approved for the treatment of this condition. IgAN is a rare kidney disease) and a leading cause of kidney failure due to glomerular disease, affecting up to 150,000 people in the U.S., with approximately 30,000 to 50,000 of such patients estimated to be addressable under the indication approved via accelerated approval.
- Advise patients with symptoms suggesting hepatotoxicity to immediately stop treatment with Filspari and seek medical attention.
- Monitor serum potassium periodically and treat appropriately.
- Fluid retention may occur.
- There was a greater incidence of hypotension-associated adverse events, some serious, in patients treated with Filspari compared to irbesartan.
- Avoid use of Filspari in patients with any hepatic impairment.
- Filspari can cause fetal harm.
The Company expects Filspari to be available beginning the week of February 27, 2023, and will be providing a comprehensive patient support program throughout the patient’s treatment journey.