Federal health officials have cleared the way for broader use of a Travere Therapeutics medication to address a uncommon kidney condition, the pharmaceutical company announced Monday.
The regulatory decision marks Sparsentan as the initial FDA-sanctioned treatment for focal segmental glomerulosclerosis (FSGS), a kidney ailment that creates scarring in filtering components and may result in protein appearing in urine, body swelling, and complete kidney failure.
The medication works by targeting and blocking two critical receptors to shield kidney cells, which helps minimize protein loss and delays how quickly the disease advances.
This approval comes after federal drug regulators extended their evaluation period in January to gather additional information about the treatment’s clinical effectiveness.
The same drug already has regulatory clearance under the commercial name Filspari for slowing kidney deterioration in adults diagnosed with IgA nephropathy, a advancing autoimmune disorder.
According to Travere, kidney specialists can begin writing prescriptions for FSGS patients right away.
Company data indicates FSGS impacts more than 40,000 individuals across the United States, with comparable numbers affected throughout Europe.
The pharmaceutical firm sets Filspari’s cost at $9,900 monthly for IgA nephropathy treatment, totaling roughly $170,000 annually.
Jefferies analyst Maury Raycroft shared with Reuters: “We think the price should be approximately 2x of what they’re charging for IgAN, and that’s because of the higher dose.”
Financial analysts at Jefferies project the medication could generate peak revenue of $961 million by 2033 for this particular condition.
Travere secured licensing rights to the drug from Ligand Pharmaceuticals in 2012 through an arrangement that provides Ligand with milestone payments and a 9% share of worldwide sales.
Filspari, which received approval in 2023 for IgA nephropathy, includes serious warnings about potential liver injury and birth complications.
Meanwhile, Swiss pharmaceutical company Novartis is conducting mid-stage testing of its competing drug, atrasentan, for FSGS patients.
During the three-month period ending December 31, Filspari recorded $103.3 million in sales revenue.
