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Trade names | Filspari |
Other names | RE-021, PS433540 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a623018 |
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Routes of administration | By mouth |
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ChEBI | |
ECHA InfoCard | 100.275.317 |
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Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy. [1] Sparsentan is an endothelin and angiotensin II receptor antagonist. [1] [4] It is taken by mouth. [1]
The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood. [5]
It was approved for medical use in the United States in February 2023. [5] [6] [7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]
Sparsentan is indicated to reduce proteinuria in people with primary immunoglobulin A nephropathy. [1] [5]
The most common side effects include swelling of the extremities, low blood pressure, dizziness, high blood potassium, anemia, injury to the kidney, and increased liver enzymes in the blood. [5]
Other potential risks of sparsentan include low blood pressure, injury to the kidney, high potassium in the blood, and fluid retention. [5] Sparsentan can cause changes in liver tests. [5] Some medicines that are like sparsentan can cause liver failure. [5]
Sparsentan can cause serious birth defects if taken during pregnancy and should not be started in someone who is pregnant. [5]
Sparsentan was discovered by Pharmacopeia, Inc. and developed as PS433540 as their lead compound in a new class of agents called dual acting receptor antagonists (DARA). PS433540 was originally developed as a treatment for hypertension and diabetic nephropathy. [9] After Pharmacopeia was acquired by Ligand Pharmaceuticals, the DARA programs was licensed to Retrophin and developed as RES-021 in 2012. [10] Retrophin would then be rebranded as Travere Therapeutics. [11]
Sparsentan was evaluated in a randomized, double-blind, active-controlled, clinical trial (PROTECT) in participants with IgA nephropathy. [5] Participants with IgA nephropathy and protein in the urine were randomly assigned to receive either sparsentan or irbesartan once daily. [5] The primary endpoint for accelerated approval was the mean change in urine protein at week 36 compared to baseline. [5]
The US Food and Drug Administration (FDA) granted accelerated approved to sparsentan based on evidence from a clinical trial (PROTECT) of participants with IgA nephropathy. [5] The trial was conducted at 156 sites in 18 countries in North America, Europe, and Asia-Pacific. [5] The same trial was used to assess both efficacy and safety. [5] The efficacy analyses were based on an interim analysis of 281 participants (141 on sparsentan, 140 on irbesartan) who reached week 36 in the trial. [5] The safety analyses were based on 404 participants (202 each on sparsentan and irbesartan) who received at least one dose of either drug. [5]
Sparsentan was approved in the US under accelerated approval based on reduction of proteinuria. [1] [5] [12] In September 2024, the US FDA converted the conditional approval in the kidney disease IgA nephropathy (IgAN) into a full approval based on positive long-term confirmatory results from the PROTECT Study demonstrating that sparsentan significantly slowed kidney function decline over two years compared to irbesartan. [13] [14]
In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorization for the medicinal product Filspari, intended for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). [2] The applicant for this medicinal product is Vifor France. [2] Sparsentan was approved for medical use in the European Union in April 2024. [2] [3]
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