Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss

Travere Therapeutics, Inc. is optimistic about getting full approval for Filspari (sparsentan) in immunoglobulin A nephropathy (IgAN) based on results from the confirmatory Phase III PROTECT trial, anticipating that the US Food and Drug Administration will take the “totality of data” into account despite the trial not reaching statistical significance on its primary endpoint.

On 21 September, Travere announced the results for PROTECT, which compared Filspari against the generic drug irbesartan in IgAN patients. The company said that although the trial showed a clinically meaningful difference for Filspari versus irbesartan on estimated glomerular filtration rate (eGFR) total slope, that result did not reach statistical significance (p=0.058). The difference was statistically significant on eGFR chronic slope (p=0.037)