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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US FDA lauds collaborative development of surrogate endpoint that allowed for accelerated approval of the first two drugs for the rare kidney disease. The program was presented as an example of novel endpoints for rare diseases at a Duke/FDA workshop.
Travere’s drug, approved as Filspari for immunoglobulin A nephropathy, missed its eGFR primary endpoints in focal segmental glomerulosclerosis but showed meaningful improvement in proteinuria.