Travere Therapeutics Announces Full FDA Approval of FILSPARI® (sparsentan), the Only ...
FDA grants full approval to FILSPARI (sparsentan) for IgA nephropathy (IgAN), based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI is an oral, non-immunosuppressive, once-daily treatment targeting glomerular injury, with a durable benefit on proteinuria and kidney function over two years.
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FDA grants full approval to FILSPARI for IgA nephropathy, based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI, an oral, non-immunosuppressive treatment, targets glomerular injury and reduces proteinuria, positioning it as foundational care for IgAN.
FDA approves Travere Therapeutics’ Filspari (sparsentan) for IgA nephropathy, the first non-immunosuppressive treatment to significantly slow kidney function decline. Based on the PROJECT study, Filspari outperformed irbesartan in preserving kidney function over two years. Common adverse events include hyperkalemia and hypotension.
FDA grants full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, non-immunosuppressive treatment for IgAN, targeting glomerular injury. CEO Eric Dube highlights Filspari's potential as foundational care for IgAN. Jefferies analyst Maury Raycroft notes Filspari's alignment with new KDIGO guidelines. Filspari, a small molecule blocker of endothelin and angiotensin II receptors, comes with boxed warnings for hepatotoxicity and embryo-fetal toxicity. Travere competes with Calliditas and Novartis in the IgAN treatment space.
The FDA granted full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, removing the UPCR requirement. The approval includes boxed warnings for hepatotoxicity and birth defects, necessitating a REMS program and regular kidney function monitoring. Despite earlier data requests for FSGS treatment, the approval is based on the PROTECT trial's modified analysis showing Filspari's efficacy in slowing kidney function decline.
IgA nephropathy (IgAN) is a common autoimmune kidney disease characterized by IgA deposits, leading to progressive damage and chronic kidney disease (CKD). 40-53% of patients progress to end-stage renal disease (ESRD) within two decades, necessitating interventions like dialysis or transplantation. The treatment landscape for IgAN is evolving with ongoing phase 3 trials for 11 agents, including budesonide and sparsentan, which have received FDA approval. Early detection and intervention are crucial to delay progression, reduce healthcare costs, and improve patient outcomes.
The FDA has fully approved sparsentan (Filspari; Travere Therapeutics), an oral, non-immunosuppressive medication that significantly slows kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN). The approval is based on the PROTECT study, which showed a 1.2 mL/min/1.73m²/year treatment effect over 2 years compared to irbesartan. Sparsentan is well-tolerated and offers a superior option for preserving kidney function.
Travere Therapeutics won full approval for Filspari, treating a rare autoimmune disease affecting the kidneys.
FDA grants full approval to Travere Therapeutics’ Filspari (sparsentan) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN), supported by phase 3 PROTECT study results showing significant kidney function preservation over two years compared to irbesartan.
FDA grants full approval to Filspari, a daily oral, non-immunosuppressive medication, to slow kidney function decline in adults with primary IgA nephropathy. The approval is based on the phase 3 PROTECT study, which showed that Filspari significantly slowed kidney function decline compared to irbesartan.
Recent advancements in IgA nephropathy (IgAN) treatment include FDA approval of sparsentan (Filspari) and budesonide (Tarpeyo), with more drugs like iptacopan (Fabhalta) in development, marking significant progress in managing kidney function loss.
FDA grants full approval to FILSPARI (sparsentan) for IgA nephropathy (IgAN), based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI is an oral, non-immunosuppressive, once-daily treatment targeting glomerular injury, with potential to become foundational care in IgAN.
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FDA grants full approval to FILSPARI (sparsentan) for IgA nephropathy (IgAN), based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI is an oral, non-immunosuppressive, once-daily treatment targeting glomerular injury, with a durable benefit on proteinuria and kidney function over two years.
Travere Therapeutics' drug Filspari, for IgAN, received full FDA approval based on long-term data showing significant kidney function decline slowing. This expands the eligible patient population beyond initial proteinuria thresholds, potentially increasing market opportunity. Filspari competes with Novartis' Fabhalta and Calliditas' Tarpeyo, both also approved for IgAN. Filspari carries a black box warning for liver toxicity and is under a REMS program. Travere reported $46.9 million in Filspari revenue for H1 2024, with growth expected as approvals expand globally.
Travere Therapeutics announces FDA full approval of Filspari (sparsentan) to slow kidney function decline in IgA nephropathy, based on PROTECT Study results showing significant benefit over irbesartan.
Travere Therapeutics' stock surged after FDA full approval for kidney disease treatment Filspari, expanding market potential to over 70,000 IgA patients in the U.S. and raising peak sales estimates to $661 million. The approval aligns with Calliditas Therapeutics' similar FDA approval for Tarpeyo in December 2023.
FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.
FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.
The FDA granted full approval to Travere Therapeutics’ sparsentan (Filspari) for proteinuria reduction in adults with IgA nephropathy (IgAN) at risk of rapid disease progression, based on 2-year results from the phase 3 PROTECT study. This makes sparsentan the second therapeutic to receive full approval for IgAN, following Calliditas Therapeutics’ budesonide. The PROTECT study demonstrated long-term kidney function preservation with sparsentan, showing a clinically meaningful difference in eGFR slope versus irbesartan.
FDA grants full approval to FILSPARI for IgA nephropathy, based on PROTECT Study results showing superior kidney function preservation over irbesartan.
Travere Therapeutics receives FDA full approval for Filspari (sparsentan) to slow kidney function decline in IgAN patients. Filspari is an oral, once-daily, non-immunosuppressive medication targeting two key pathways in IgAN progression. The approval is based on the Phase 2 PROTECT Study results showing significant kidney function preservation compared to irbesartan.
FDA grants full approval to Filspari® (sparsentan) for slowing kidney function decline in adults with IgA nephropathy at risk of progression. The approval is based on the PROTECT trial's final analysis, showing sparsentan reduced the rate of kidney function decline compared to irbesartan, with a treatment effect of 1.2 mL/min/1.73m² per year.