FDA Grants Full Approval to Travere’s Filspari for IgA Nephropathy Treatment
Full FDA Approval:
The FDA granted full approval to Travere Therapeutics' Filspari (sparsentan) for the treatment of patients with primary IgA nephropathy (IgAN), a rare progressive kidney disease.
Expanded Indication:
Filspari's full approval expands its indication to include slowing the decline of kidney function in adult patients at risk of disease progression, without a specific urinary protein level requirement.
Clinical Benefits:
Long-term follow-up data from the PROTECT study showed that Filspari significantly slowed the decline in kidney function and provided durable benefits on proteinuria through 110 weeks.
Competitive Landscape:
Filspari competes with Novartis' Fabhalta and Calliditas' Tarpeyo in the IgAN treatment space.
Safety Information:
Filspari comes with a boxed warning for hepatotoxicity and embryo-fetal toxicity and is available only through a risk evaluation and mitigation strategies program.
KDIGO Guidelines:
Filspari aligns with the new KDIGO guidelines, which lowered the urine protein-creatinine ratio (UPCR) threshold for at-risk patients and raised treatment goals.