FDA grants accelerated approval to Filspari for reduced proteinuria in IgA nephropathy
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Travere Therapeutics announced the FDA granted accelerated approval to Filspari, also known as sparsentan, according to a company press release.
Filspari is a once-daily oral medication designed to reduce proteinuria in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression. The medication is the first and only non-immunosuppressive therapy approved for this condition.
“The accelerated approval of [Filspari] is a significant milestone on our path to advancing a transformative treatment for the IgA nephropathy community,” Eric Dube, PhD, president and chief executive officer of Travere Therapeutics, said in the release. “As a first-of-its-kind, non-immunosuppressive therapy, we believe [Filspari] has the potential to ultimately become the new standard of care for IgA nephropathy and offer hope to those living with this condition who until now have had few treatment options. We are grateful to the patients, caregivers, clinical trial investigators, healthcare providers and advocates who have worked alongside us to develop this innovative first-in-class therapy.”
According to the press release, further approval of Filspari may depend on results of the ongoing phase 3 Protect Study which is exploring whether the medication can slow kidney function decline. This study has already shown that Filspari improves proteinuria compared to an active comparator.
In the second quarter of 2023, Travere Therapeutics expects a review decision by the European Medicines Agency on approval of the Conditional Marketing Authorization application for sparsentan in Europe. Additionally, the second quarter may bring results from the ongoing Phase 3 Duplex Study investigating sparsentan in focal segmental glomerulosclerosis, according to the release.
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