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.
Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.
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