Irbesartan

sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS If approved, FILSPARI could become the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure Additionally, the FDA notified the Company that REMS monitoring for embryo-fetal toxicity is no longer necessary; the Company plans to submit an amendment to the REMS sNDA currently under review for modification of liver monitoring March 17, 2025 Travere Therapeutics Inc., (Nasdaq: TVTX) today announced the Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking priority review for traditional approval of FILSPARI® (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The submission is supported by results from the Phase 3 DUPLEX Study and the Phase 2 DUET Study, two of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with FSGS. “There is a profound and urgent need for effective treatment options that can target glomerular injury, reduce proteinuria, and preserve kidney function in FSGS,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “Since its approval in IgA nephropathy, we have seen the positive impact FILSPARI can have on patients living with rare kidney disease. We have great hope to potentially bring FILSPARI as the first approved treatment for patients with FSGS and this sNDA submission is an important next step toward that goal. We look forward to the upcoming review process.” FILSPARI is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). It is currently approved to slow kidney function decline in adults with IgA nephropathy, a leading cause of kidney failure. The DUPLEX and DUET studies demonstrated that FILSPARI provided rapid, superior and sustained reductions in proteinuria when compared with maximum labeled dose irbesartan, in children and adults with FSGS. In the DUPLEX and DUET studies, FILSPARI was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date. The FDA has 60 days from the receipt of the application to determine whether to accept it for review. The Company expects to receive notice regarding the acceptance for review of the sNDA submission as well as the timeline for sNDA review from the FDA in the second quarter of 2025. Additionally, the FDA recently notified the Company that the REMS is no longer necessary to ensure the benefits of FILSPARI outweigh the risk of embryo-fetal toxicity and to minimize the burden on the healthcare delivery system. The Company plans to submit a REMS modification to remove the need to monitor the risk of embryo-fetal toxicity as an amendment to the REMS sNDA currently under review for potential modification of liver monitoring. The FDA indicated that this amendment is not expected to impact the review timeline and the Company continues to expect a REMS modification PDUFA target action date of August 28, 2025. Focal segmental glomerulosclerosis (FSGS) is a rare proteinuric kidney disorder in both children and adults that is estimated to affect more than 40,000 patients in the U.S. with similar prevalence in Europe. The disorder is defined by progressive scarring of the kidney and often leads to kidney failure. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney. Once in the urine, protein is considered to be toxic to other parts of the kidney, especially the tubules, and is believed to contribute to further disease progression. Other common symptoms include swelling in parts of the body, known as edema, as well as low blood albumin levels, abnormal lipid profiles and hypertension. There are currently no FDA-approved pharmacologic therapies for FSGS. The Phase 3 DUPLEX Study is the largest interventional study to date in FSGS, and the only study in FSGS against a maximally dosed active comparator. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria (FPRE) endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. The two-year results from the study were published in the New England Journal of Medicine and showed that sparsentan delivered clinically meaningful benefit at 108 weeks with significant proteinuria reduction, higher rates of partial and complete remission, and a lower rate of end-stage kidney disease compared to the active control. The Phase 2 DUET Study of sparsentan in FSGS met the primary efficacy endpoint for the combined treatment group, demonstrating a greater than two-fold reduction in proteinuria compared to irbesartan. Sparsentan was well-tolerated with a safety profile that was consistent across all clinical trials conducted to date and comparable to the active control, irbesartan, including no drug-induced liver injury and no fluid overload. Patients who completed the DUPLEX and DUET double-blind portions of the studies on treatment were eligible to participate in the open-label extension of the trials. At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit travere.com The content above comes from the network. if any infringement, please contact us to modify.