The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.’s (NASDAQ:TVTX) Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for IgA nephropathy (IgAN).TVTX is surging to new heights today. See what is driving the movement here.The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with Filspari. It removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.The reduction of Filspari liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from post-marketing surveillance as well as the Phase 3 PROTECT Study in ...Full story available on Benzinga.com
FDA Eases Monitoring Burden For Kidney Disease Patients On Travere Therapeutics' Filspari
