Filspari FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 9, 2024.
FDA Approved: Yes (First approved February 17, 2023)
Brand name: Filspari
Generic name: sparsentan
Dosage form: Tablets
Company: Travere Therapeutics, Inc.
Treatment for: Primary Immunoglobulin A Nephropathy
Filspari (sparsentan) is an endothelin and angiotensin II receptor antagonist indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
- IgA nephropathy (IgAN) is a rare kidney disorder characterized by the buildup of immunoglobulin A (IgA) in the kidneys. Deposits of IgA in the kidneys cause a breakdown of the normal filtering mechanisms, leading to proteinuria and hematuria. Other symptoms may include kidney pain, edema, and high blood pressure.
- Filspari is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) that works to reduce proteinuria in IgAN by selectively targeting the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). Blockade of the endothelin type A and angiotensin II type 1 pathways limits IgA nephropathy progression by reducing proteinuria, protecting podocytes, and preventing glomerulosclerosis and mesangial cell proliferation.
- Filspari tablets are administered orally once daily.
- Filspari carries a Boxed Warning for hepatotoxicity and embryo-fetal toxicity. Filspari is available only through a Risk Evaluation and Mitigation Strategy (REMS) approved by the FDA.
- Warnings and precautions associated with Filspari include hepatotoxicity, embryo-fetal toxicity, hypotension, acute kidney injury, hyperkalemia, and fluid retention.
- Common adverse reactions include peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.
Development timeline for Filspari
Further information
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