08:45 AM EDT, 03/11/2024 (MT Newswires) -- Travere Therapeutics ( TVTX ) said Monday that it has submitted a supplemental New Drug Application to the US Food and Drug Administration for seeking full approval of Filspari in IgA nephropathy.
The company said the submission is based on results from a late-stage study in which Filspari showed "long-term kidney function preservation" and reduced protein in the urine.
Travere said it expects receiving notice about the acceptance for review of the sNDA submission and the timeline from the regulator during Q2.
The company said Filspari received accelerated approval from the US FDA in February last year to treat glomerular injury in the kidney to reduce proteinuria in adult patients with primary IgA nephropathy.
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