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The FDA granted accelerated approval to sparsentan (Filspari) for proteinuria in IgA nephropathy, Travere Therapeutics announced, marking the first non-immunosuppressive therapy for this
rare condition.
Also known as Berger's disease, proteinuria in IgA nephropathy is the leading cause of kidney failure due to glomerular disease, and sparsentan is specifically indicated to reduce
proteinuria in adults at risk of rapid disease progression -- typically those with a urine protein-to-creatinine ratio of 1.5 g/g or higher.
The once-daily oral drug works by selectively targeting two critical pathways in the disease progression of IgA nephropathy -- endothelin-1 and angiotensin II.
Underpinning the approval is the phase III PROTECT study, which compared 400 mg of sparsentan with 300 mg of irbesartan in 404 adult patients with IgA nephropathy and persistent proteinuria
even with angiotensin-converting enzyme (ACE) therapy or angiotensin-receptor blockers (ARBs). Patients on sparsentan achieved an average proteinuria reduction of 50% from baseline versus a
drop of 15% in irbesartan-treated patients after 36 weeks, meeting the trial's primary endpoint (P