Filspari FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2023.
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 reduce proteinuria in adults with primary immunoglobulin A nephropathy.
- 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.
- The approval of Filspari was granted under the FDA's accelerated approval pathway based on reduction of proteinuria. It has not been established whether Filspari slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
- 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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