Travere Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for FILSPARI® (sparsentan) to help slow the decline of kidney function in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. FILSPARI targets glomerular damage in the kidneys by blocking two key pathways that lead to IgAN progression, endothelin-1 and angiotensin II. This full approval follows long-term results from the PROTECT study, showing FILSPARI significantly slows kidney function decline over two years, compared to irbesartan.The PROTECT study, involving 404 patients, demonstrated a significant reduction in the decline of kidney function in patients taking FILSPARI compared to those taking irbesartan. The mean decline in kidney function was reduced by 1.2 mL/min/1.73 m² per year (p=0.0168), showing a durable effect on proteinuria and overall kidney function over a two-year period.The treatment has been well tolerated across clinical trials, with a consistent safety profile.

FILSPARI通过阻断导致IgAN进展的两个关键途径内皮素-1和血管紧张素II来靶向肾脏中的肾小球损伤。这一全面批准是在PROTECT研究的长期结果之后得出的，该研究表明，与厄贝沙坦相比，FILSPARI在两年内显着减缓了肾功能的下降。PROTECT研究涉及404名患者，与服用厄贝沙坦的患者相比，服用FILSPARI的患者肾功能下降明显减少。肾功能的平均下降每年减少1.2 mL/min/1.73 m²（p=0.0168），显示出在两年内对蛋白尿和整体肾功能的持久影响。该治疗在整个临床试验中耐受性良好，具有一致的安全性。

Travere Therapeutics is planning to submit a supplemental New Drug Application (sNDA) to modify liver monitoring requirements under the REMS (Risk Evaluation and Mitigation Strategies) program.IgA nephropathy (IgAN), or Berger’s disease, is a rare, progressive kidney condition where immunoglobulin A (IgA) builds up in the kidneys, leading to damage.

Travere Therapeutics计划提交补充新药申请（sNDA），以修改REMS（风险评估和缓解策略）计划下的肝脏监测要求。IgA肾病（IgAN）或伯格氏病是一种罕见的进行性肾脏疾病，免疫球蛋白a（IgA）在肾脏中积聚，导致损伤。

This can result in blood and protein in the urine, swelling, and high blood pressure. It is the most common type of glomerular disease worldwide and a leading cause of kidney failure. IgAN affects up to 150,000 people in the U.S. and is prevalent in Europe and Japan.The drug previously received accelerated approval in February 2023, based on the reduction of proteinuria (excess protein in urine), a key indica.

这可能导致血液和尿液中的蛋白质，肿胀和高血压。它是全球最常见的肾小球疾病类型，也是肾衰竭的主要原因。IgAN在美国影响多达150000人，在欧洲和日本很普遍。该药物之前于2023年2月获得加速批准，基于减少蛋白尿（尿液中过量蛋白质），这是一个关键指标。