FDA Grants Accelerated Approval To Travere's Filspari For IgA Nephropathy Treatment

(RTTNews) - Travere Therapeutics Inc. (TVTX) said that the U.S. Food and Drug Administration granted accelerated approval to Filspari (sparsentan) to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. The company expects Filspari to be available beginning the week of February 27, 2023.

The continued approval of Filspari may be contingent upon confirmation of a clinical benefit in the ongoing Phase 3 Protect Study, which is designed to demonstrate whether Filspari slows kidney function decline.

Topline results from the two-year confirmatory endpoints in the Protect Study are expected in the fourth quarter of 2023 and are intended to support traditional approval of Filspari.

IgA nephropathy, also called Berger's disease, is a rare kidney disorder characterized by the build-up of the protein immunoglobulin A (IgA) in the kidneys. The accumulation of IgA hinders the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), and protein in the urine (proteinuria).

Sparsentan is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) that selectively targets the endothelin A receptor (ET A R) and the angiotensin II subtype 1 receptor (AT 1 R). This compound is designed to sustainably reduce proteinuria and protect the long-term health of kidneys in people living with IgA nephropathy.

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