Travere Therapeutics (TVTX) Study update summary

FDA approval and clinical significance

• FILSPARI (sparsentan) received FDA approval to reduce proteinuria in adults and pediatric patients aged eight and older with FSGS without nephrotic syndrome, becoming the first and only approved therapy for this condition.

• Approval is based on phase III DUPLEX study data, showing significant reductions in proteinuria, improved eGFR, and kidney outcomes in the defined patient population.

• FILSPARI demonstrated a 48% reduction in proteinuria versus 27% for irbesartan at week 108, and a 29% greater reduction in UPCR from baseline (p=0.0075), with favorable eGFR outcomes and lower progression to kidney failure (RR: 0.19, p=0.018).

• FILSPARI achieved more than three times higher complete remission rates at key proteinuria thresholds versus irbesartan.

• The safety profile was comparable to irbesartan and consistent across clinical subgroups, with common adverse reactions including peripheral edema, hypotension, hyperkalemia, dizziness, anemia, and transaminase elevations; liver monitoring is required.

Patient population and clinical practice

• FSGS is a rare, severe, and progressive kidney disease with the lowest 7-year kidney survival rate among primary glomerular diseases, often leading to kidney failure and high unmet need.

• Less than 20% of FSGS patients have active nephrotic syndrome at a single point in time; the condition is relapsing and remitting.

• Over 4,000 people in the U.S. are on the kidney transplant waitlist due to FSGS, and up to 55% of transplant patients experience disease recurrence.

• Median time to kidney failure is 5–10 years for 30–60% of patients.

• The addressable US patient population for FILSPARI now exceeds 30,000 FSGS patients, with the total addressable population over 100,000 including IgAN.

Commercial strategy and market opportunity

• FILSPARI's launch in FSGS builds on its established presence in IgA nephropathy, leveraging existing commercial infrastructure and physician relationships, with over 100 field professionals and expanded sales coverage to 7,000 nephrologists.

• Over 80% of nephrologists view FSGS as a high unmet need and are familiar with FILSPARI, which is the most desired product candidate among specialists.

• FILSPARI is already included in many payer formularies for IgA nephropathy, supporting rapid access for FSGS patients.

• The estimated U.S. peak opportunity for FILSPARI exceeds $3 billion, with growth expected from expanding indications and increased patient identification.

• No significant bolus of patients is expected at launch; uptake will follow regular nephrology visit cadence.