FDA Approves Travere’s Filspari Treatment Of Rare Kidney Disease IgA Nephropathy

Travere Therapeutics has achieved a major milestone with the FDA granting full approval for Filspari, a groundbreaking treatment designed to slow kidney function decline in adults with primary IgA nephropathy (IgAN). Affecting around 150,000 people in the U.S., IgAN is a rare but serious kidney disease that can lead to severe health complications.

IgA nephropathy occurs when immunoglobulin A builds up in the kidneys, impairing their ability to filter waste from the blood. Filspari, oral non-immunosuppressive drug used once daily, was initially granted accelerated FDA approval in February 2023 for patients at high risk of rapid disease progression. Now, with full approval, the drug is available for all patients at risk of disease progression. This decision is based on the successful results from the phase 3 study, which demonstrated that Filspari slowed kidney function decline over two years compared to irbesartan, while maintaining a strong safety profile.

Travere Therapeutics’ CEO, Eric Dube, expressed optimism, noting that this approval allows for wider prescribing of he drug, which offers a safer and more effective treatment option than existing therapies. The news follows closely after the FDA’s approval of Novartis’ Fabhalta, highlighting increased focus on therapies for IgAN.

Filspari marks a significant advancement in the treatment of IgAN, offering patients a non-immunosuppressive alternative that promises better kidney function preservation and quality of life. This approval is a crucial step forward in addressing the needs of those suffering from rare kidney diseases.