The whole article is worth a read.
https://www.fiercepharma.com/pharma/trial-scare-travere-filspari-fda-full-approval-kidney-disease-showdown-novartisTravere hasn’t given up on Filspari in another kidney disease, focal segmental glomerulosclerosis (FSGS), after it had failed the primary endpoint in a phase 3 trial, which looked at the eGFR slope.
A collaborative global project called PARASOL is examining the relationship between proteinuria and kidney failure in FSGS to potentially support the marker as a surrogate endpoint for regulatory approvals, Inrig noted. Once Travere gets a clearer understanding of that pathway likely this year, it plans to re-engage with the FDA about a potential filing, Dube said.
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