According to the Zhongtong Finance APP, on September 7, Travere Therapeutics (TVTX.US) announced that the U.S. FDA has fully approved the "first-in-class" therapy Filspari (sparsentan) for slowing the decline in kidney function in adult patients with primary IgA nephropathy (IgAN) at risk of disease progression. Filspari received accelerated approval from the FDA in February 2023 based on surrogate endpoints for proteinuria. The complete approval is based on the long-term confirmatory PROTECT study, which demonstrated that Filspari significantly slowed kidney function decline within two years and showed superior efficacy compared to active control drugs.

It is worth mentioning that Filspari is listed as one of the 15 potential blockbuster therapies to watch in 2023 by the analytics company Clarivate.

It is reported that PROTECT is a 2-year head-to-head study for IgAN, in which patients received treatment with Filspari or the active control drug irbesartan. Trial data showed that in the final analysis including 404 randomly assigned patients, Filspari significantly slowed the rate of kidney function decline from baseline to week 110 compared to the active control drug.

In the intention-to-treat analysis, the average estimated glomerular filtration rate (eGFR) slope from baseline to week 110 in the Filspari group was -3.0 mL/min/1.73 m²/year, compared to -4.2 mL/min/1.73 m²/year in the active control group (p=0.0168). Compared to the active control group, the proteinuria treatment effect observed at week 36 with Filspari persisted throughout the two-year measurement period. These study results have been published in the medical journal The Lancet.