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Home » Travere’s Filspari safari bags full FDA nod in IgAN; REMS next
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Travere’s Filspari safari bags full FDA nod in IgAN; REMS next

Sep. 6, 2024
By Randy Osborne
With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.
BioWorld Regulatory Genitourinary/sexual function Immune Nephrology Small molecule U.S. FDA

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