FDA加速批准司帕生坦(Sparsentan)用于减少IgA肾病的蛋白尿

Sparsentan is an endothelin and angiotensin II receptor antagonist developed by TravereTherapeutics. The drug received accelerated approval from the FDA in February 2023 for reducing proteinuria in patients with IgA nephropathy. Based on positive long-term data from the PROTECT study, which showed that sparsentan significantly slowed the decline in kidney function compared with irbesartan over a two-year treatment period, sparsentan was fully approved by the FDA in May 2024 to slow the decline in kidney function in adult patients with primary IgA nephropathy who are at risk of disease progression.

Sparsentan (Sparsentan) approved indications

IgA nephropathy

Sparsentan (Sparsentan) is suitable for slowing the decline in renal function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

About Sparsentan

About Sparsentan, a once-daily oral medication designed to selectively target two key pathways in IgAN disease progression (endothelin 1 and angiotensin II), is the first and only non-immunosuppressive therapy approved to treat this condition. Sparsentan is a prescription drug used to reduce proteinuria in adults with primary IgAN who are at risk for rapid disease progression, typically with UPCR ≥1.5g/g.

About IgA nephropathy

IgA nephropathy (IgAN) is a rare kidney disease characterized by the accumulation of immunoglobulin A (IgA) in the kidneys. The deposition of IgA in the kidneys can lead to disruption of the normal filtration mechanism, leading to proteinuria and hematuria. Other symptoms may include kidney pain, edema, and high blood pressure.

Sparsentan (Sparsentan) Important Safety Information

1. Sparsentan (Sparsentan) carries a black box warning of hepatotoxicity and embryo-fetal toxicity.

2. Warnings and precautions related to Sparsentan include hepatotoxicity, embryo-fetal toxicity, hypotension, acute kidney injury, hyperkalemia and fluid retention.

3. Common adverse reactions of Sparsentan include peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia and anemia.