FDA grants full approval to Filspari for IgA nephropathy

FDA granted full approval to sparsentan (Filspari) to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression. The drug, an endothelin and angiotensin II receptor antagonist, was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval was based on confirmatory data from the PROTECT trial showing that sparsentan significantly slowed kidney function decline over two years compared with irbesartan.