Sparsentan

FDA grants full approval to Filspari, a daily oral, non-immunosuppressive medication, to slow kidney function decline in adults with primary IgA nephropathy. The approval is based on the phase 3 PROTECT study, which showed that Filspari significantly slowed kidney function decline compared to irbesartan.

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FDA grants full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, non-immunosuppressive treatment for IgAN, targeting glomerular injury. CEO Eric Dube highlights Filspari's potential as foundational care for IgAN. Jefferies analyst Maury Raycroft notes Filspari's alignment with new KDIGO guidelines. Filspari, a small molecule blocker of endothelin and angiotensin II receptors, comes with boxed warnings for hepatotoxicity and embryo-fetal toxicity. Travere competes with Calliditas and Novartis in the IgAN treatment space.

FDA grants full approval to FILSPARI (sparsentan) for IgA nephropathy (IgAN), based on PROTECT Study results showing superior kidney function preservation over irbesartan. FILSPARI is an oral, non-immunosuppressive, once-daily treatment targeting glomerular injury, with a durable benefit on proteinuria and kidney function over two years.

The FDA granted full approval to Travere Therapeutics’ sparsentan (Filspari) for proteinuria reduction in adults with IgA nephropathy (IgAN) at risk of rapid disease progression, based on 2-year results from the phase 3 PROTECT study. This makes sparsentan the second therapeutic to receive full approval for IgAN, following Calliditas Therapeutics’ budesonide. The PROTECT study demonstrated long-term kidney function preservation with sparsentan, showing a clinically meaningful difference in eGFR slope versus irbesartan.

FDA grants full approval to Travere Therapeutics' Filspari for IgA nephropathy, removing urine protein level requirement. Filspari, a dual-action drug, aims to preserve kidney function and is expected to gain broader nephrologist adoption. Despite liver toxicity monitoring requirement, Filspari's launch is progressing well, with $27.1 million in Q2 sales.