FDA approves REMS modification for Filspari (sparsentan) in IgA nephropathy – Travere Theraputics

Travere Therapeutics, Inc., announced that the FDA has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Filspari (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with Filspari and removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.

“Filspari is becoming a foundational treatment for people living with IgA nephropathy, giving patients and their families hope for slowing the progression of their disease,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics. “Today’s approval of streamlined monitoring requirements reflects the strong safety profile of Filspari established to date across clinical and real-world use, simplifying access for patients.”

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 III PROTECT Study in IgAN, the Phase III DUPLEX Study, and the Phase II DUET Study in focal segmental glomerulosclerosis (FSGS).

The FDA determined that the REMS requirement for EFT for Filspari was no longer necessary following an analysis of human pregnancy data compiled from the use of ERA medicines from the last two decades.