Travere Therapeutics Secures Full FDA Approval for FILSPARI in Treating IgA Nephropathy

Full FDA Approval:
The FDA granted full approval to Travere Therapeutics' FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.

Expanded Indication:
The approval expands FILSPARI's indication, allowing its use to slow the decline of kidney function in adult patients with IgAN, without the previous requirement of a specific urinary protein level.

PROTECT Study Results:
The approval is based on positive long-term benefits from the PROTECT Study, which demonstrated FILSPARI's significant benefits in preserving kidney function and reducing proteinuria over a two-year period compared to irbesartan.

Safety Profile:
FILSPARI was found to be well-tolerated with a consistent safety profile across all clinical trials conducted to date.

Market Competition:
FILSPARI competes with Novartis' Fabhalta and Calliditas' Tarpeyo in the IgAN treatment space.

Travere TotalCare Program:
Travere Therapeutics offers a comprehensive patient support program, Travere TotalCare, to assist patients and their caregivers in navigating the treatment process.

KDIGO Guidelines:
FILSPARI aligns with the new Kidney Disease Improving Global Outcomes (KDIGO) guidelines, which lowered the urine protein-creatinine ratio (UPCR) threshold for at-risk patients and raised treatment goals.