Travere Therapeutics Gains FDA Approval for FILSPARI®
Friday, September 06, 2024
Travere Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has granted full approval for FILSPARI® (sparsentan) to help slow the decline of kidney function in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression.
FILSPARI targets glomerular damage in the kidneys by blocking two key pathways that lead to IgAN progression, endothelin-1 and angiotensin II.
This full approval follows long-term results from the PROTECT study, showing FILSPARI significantly slows kidney function decline over two years, compared to irbesartan.
The PROTECT study, involving 404 patients, demonstrated a significant reduction in the decline of kidney function in patients taking FILSPARI compared to those taking irbesartan.
The mean decline in kidney function was reduced by 1.2 mL/min/1.73 m² per year (p=0.0168), showing a durable effect on proteinuria and overall kidney function over a two-year period.
The treatment has been well tolerated across clinical trials, with a consistent safety profile. Travere Therapeutics is planning to submit a supplemental New Drug Application (sNDA) to modify liver monitoring requirements under the REMS (Risk Evaluation and Mitigation Strategies) program.
IgA nephropathy (IgAN), or Berger’s disease, is a rare, progressive kidney condition where immunoglobulin A (IgA) builds up in the kidneys, leading to damage. This can result in blood and protein in the urine, swelling, and high blood pressure.
It is the most common type of glomerular disease worldwide and a leading cause of kidney failure. IgAN affects up to 150,000 people in the U.S. and is prevalent in Europe and Japan.
The drug previously received accelerated approval in February 2023, based on the reduction of proteinuria (excess protein in urine), a key indicator of the disease.
Travere Therapeutics, expressed confidence in the drug's potential to offer a safe, effective, and convenient treatment for IgAN patients. With full approval, physicians can now prescribe FILSPARI as a once-daily oral treatment, providing superior kidney function preservation compared to current standards of care.
The Ohio State University, highlighted the importance of FILSPARI’s full approval in providing a new, more effective treatment option for patients with IgAN, noting that the drug’s ability to reduce proteinuria and preserve kidney function over time represents a major advancement in patient care.
To support patients and healthcare providers, Travere Therapeutics offers a comprehensive programme, Travere TotalCare®, which assists with prescription management, insurance navigation, and patient education.
Source: travere.com
