Sparsentan in immunoglobulin A nephropathy: a profile of its use

Sparsentan (FILSPARI^®), an oral, dual endothelin and angiotensin receptor antagonist, is an emerging new treatment option for patients with immunoglobulin A (IgA) nephropathy. Sparsentan received accelerated approval in the USA for the treatment of adults with IgA nephropathy who are at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UP/C) ≥ 1.5 g/g, as well as a positive opinion recommending approval in the EU. In the ongoing phase 3 PROTECT trial in adults with IgA nephropathy, sparsentan was associated with favourable antiproteinuric effects, which were maintained over 110 weeks of treatment. The change in UP/C from baseline at week 36 was significantly greater with sparsentan than with irbesartan, an angiotensin receptor blocker. Early results from the 110-week final analysis of PROTECT also suggested that sparsentan may provide long-term benefits in preserving kidney function in patients with IgA nephropathy. Final analyses from the PROTECT trial, including its open-label extension period, are awaited with interest. Sparsentan was generally well tolerated, with its tolerability profile being similar to that of irbesartan. The most common treatment-emergent adverse events with sparsentan included peripheral oedema, hypotension, dizziness and hyperkalaemia. Longer-term data revealed no new safety signals.