Travere's FILSPARI® Gains FDA Approval for IgA Nephropathy Treatment

The U.S. Food and Drug Administration (FDA) has granted full approval for FILSPARI (sparsentan) to treat adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. This approval is based on positive long-term results from the PROTECT Study, which showed that FILSPARI significantly slowed kidney function decline over a two-year period compared to irbesartan. Initially given accelerated approval in February 2023 based on reducing proteinuria, FILSPARI's full approval now allows for its broader prescription as a once-daily, oral, non-immunosuppressive treatment.

Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics, emphasized that this approval provides a safe, effective, and convenient treatment option for IgAN patients, significantly preserving kidney function. The updated label for FILSPARI includes data demonstrating its long-term benefit, which supports its potential to replace the current standard of care in IgAN treatment. The medication has also been recommended in KDIGO's recent draft guidelines as a foundational kidney-targeted therapy.

Unlike other treatments, FILSPARI is the only oral, once-daily, non-immunosuppressive medication for IgAN that targets glomerular injury by blocking two critical pathways in disease progression: endothelin-1 and angiotensin II. The FDA-approved label reflects a two-year efficacy analysis from the PROTECT Study, encompassing data from all patients regardless of treatment discontinuation. Results showed that FILSPARI significantly reduced the rate of kidney function decline from baseline to Week 110 compared to irbesartan. Specifically, the mean eGFR slope for FILSPARI was -3.0 mL/min/1.73 m²/year against -4.2 mL/min/1.73 m²/year for irbesartan, presenting a statistically significant treatment effect.

Additionally, the study indicated that FILSPARI was well tolerated, with consistent safety profiles across all clinical trials. Discussions with the FDA are ongoing about submitting a supplemental New Drug Application (sNDA) for a potential modification to the liver-monitoring Risk Evaluation and Mitigation Strategy (REMS).

Experts in the field have praised the FDA's decision. Dr. Brad Rovin, medical director at The Ohio State University Center for Clinical Research Management, described the full approval of FILSPARI as a crucial tool for managing IgAN, highlighting its effectiveness in reducing proteinuria and preserving kidney function over time, often surpassing the current standard care.

Bonnie Schneider from the IgA Nephropathy Foundation and Josh Tarnoff, CEO of NephCure, both expressed optimism and gratitude for the approval, acknowledging the new treatment option that FILSPARI represents for patients with this rare kidney disease. They noted that this development brings much-needed hope and progress in treating IgAN and slowing kidney function decline.

Travere Therapeutics also offers a comprehensive patient support program called Travere TotalCare®, which provides resources, assistance, and services to help patients understand IgAN, manage insurance processes, and initiate treatment. The program aims to facilitate a smooth experience for patients, their caregivers, and healthcare providers.

The approval marks a significant milestone in the treatment landscape of IgAN, promising to enhance patient outcomes and offer new hope to those affected by this chronic kidney condition.

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