Travere Therapeutics Wins Much-Awaited Approval For Drug In Rare Kidney Disease

• The agency approved the drug in adult and pediatric patients aged 8 years and older.
• Travere expects that there are at least 30,000 people in the U.S. with focal segmental glomerulosclerosis but without nephrotic syndrome.  
• Filspari was previously greenlit by the FDA for the treatment of IgA nephropathy

Travere Therapeutics, Inc. (TVTX) said on Monday that the U.S. Food and Drug Administration has approved its Filspari to reduce proteinuria in some patients with focal segmental glomerulosclerosis (FSGS), making it the first FDA-approved drug for the indication.

The agency approved the drug in adult and pediatric patients aged 8 years and older. Travere expects that there are at least 30,000 people in the U.S. with focal segmental glomerulosclerosis but without nephrotic syndrome.

Filspari was previously greenlit by the FDA for the treatment of IgA nephropathy, a chronic autoimmune kidney disease characterized by the abnormal accumulation of immunoglobulin A (IgA) antibodies in the kidneys' filtering units.

Fresh Approval

While the FDA was previously expected to decide on Travere’s application by January, it pushed it to April after requesting additional information to assess Filspari’s clinical benefit. The company submitted responses, and the agency determined that the responses constitute a major amendment to the application, and extended the review timeline.

Filspari was approved in the new indication based on data from a late stage trial where FSGS patients without nephrotic syndrome who were treated with Filspari experienced a 48% reduction in proteinuria from baseline to week 108 compared to 27% for those treated with irbesartan.

FSGS is a rare and serious kidney disorder driven by proteinuria or protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. The disease leads to progressive kidney function loss and kidney failure.

While TVTX edged 0.2% lower after hours, shares of Ligand Pharmaceuticals (LGND), with which Travere has a licensing agreement for Sparsentan, sold under the Filspari brand, rose 3% at the time of writing.

How Did Retail Traders React?

On Stocktwits, retail sentiment around TVTX stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume stayed at ‘extremely high’ levels.

TVTX has gained 107% over the past 12 months. 

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