Travere Therapeutics’ Filspari in kidney function granted full approval by FDA

Travere Therapeutics announced that the FDA has granted full approval to Filspari – sparsentan – to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. Filspari was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that Filspari significantly slowed kidney function decline over two years compared to irbesartan. The two-year efficacy data showed that Filspari significantly reduced the rate of decline in kidney function from baseline to Week 110 compared to irbesartan.The positive treatment effects on proteinuria compared to the active control irbesartan that were observed at Week 36 were durable out to the two-year measurement period. Following engagement with the FDA, the company expects to submit an sNDA for a potential modification to the liver-monitoring REMS.