FDA Approves Travere’s Filspari for Treatment of Focal Segmental Glomerulosclerosis

Travere Therapeutics has received U.S. FDA approval for its Filspari (sparsentan) for treatment of focal segmental glomerulosclerosis (FSGS).

FSGS Defined

FSGS is a rare proteinuric kidney disorder, in both children and adults, characterized by progressive scarring of the kidney. A main symptom is proteinuria, in which protein leaks into the urine as the kidney’s normal filtration mechanism breaks down. Ultimately, this often leads to kidney failure.

FSGS without nephrotic syndrome, which Filspari helps reduce, spans all categories of the disorder. Travere estimates there are approximately 30,000 people in the U.S. who meet this criteria.

FDA’s approval covers adult patients plus pediatric patients age 8 and older.

Second FDA Approval for Travere’s Filspari

Filspari is already the most-prescribed FDA-approved medicine for IgA nephropathy (IgAN). Now, it is the first drug approved in the U.S. for FSGS, a second rare kidney disease.

Travere President and CEO Eric Dube, PhD, said the latest approval marks a “historic milestone” for those living with FSGS.

“This approval reflects years of perseverance and our belief that those living with FSGS deserve better,” Dube said. “[It] builds on our leadership and progress in rare kidney diseases, expanding Filspari’s potential reach to more than 100,000 people.”

Offering additional reaction was Kirk Campbell, MD, President of the National Kidney Foundation. He’s also C. Mahlon Kline Professor and Chief, Division of Renal-Electrolyte and Hypertension, Perelman School of Medicine, University of Pennsylvania.

“For decades, treatment options have been limited, often relying on off-label therapies such as long-term steroids,” Campbell said. “For patients without active nephrotic syndrome, where optimizing foundational therapy is critical, Filspari represents an important new option.”Travere says Filspari will be available immediately for nephrologists to prescribe to patients with FSGS.