Company and FDA align on a pathway to proceed with submission for accelerated approval in mid-2022 pending additional eGFR data
SAN DIEGO, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced a successful outcome from the Company’s Type A meeting with the U.S. Food and Drug Administration (FDA) in which alignment was reached on the Company’s plan to submit additional estimated glomerular filtration rate (eGFR) data from the ongoing pivotal Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) to support an application for accelerated approval in 2022.
“We are very pleased with the outcome of the Type A meeting which confirms our plan to provide FDA with additional eGFR data from the ongoing DUPLEX Study in the first half of 2022 to continue on the accelerated approval pathway for sparsentan in FSGS,” said Eric Dube, Ph.D., chief executive officer of Travere Therapeutics. “If the additional data further strengthen the prediction of long-term benefit in the study as we expect, we anticipate submitting a New Drug Application for accelerated approval of sparsentan for FSGS in the middle of next year and furthering our preparations to deliver it as a potential new treatment standard for FSGS, if approved.”
Following the outcome of the Type A meeting, the Company intends to continue with its plan to provide the FDA with additional eGFR data from the ongoing DUPLEX Study in the first half of 2022. At the time of the eGFR data cut, all patients remaining in the DUPLEX Study will have completed one year of treatment, and approximately 50 percent of patients will have completed two years of treatment. The Company plans to submit an application for accelerated approval in the U.S. in mid-2022, pending additional supportive eGFR data. The DUPLEX Study is continuing as planned with no changes to the statistical analysis plan, and patients will proceed in a blinded manner to assess the treatment effect on eGFR slope over 108 weeks in the confirmatory endpoint analysis.
About Sparsentan
Sparsentan, a Dual Endothelin Angiotensin Receptor Antagonist (DEARA), is a novel investigational product candidate. Pre-clinical data have shown that blockade of both endothelin type A and angiotensin II type 1 pathways in forms of rare chronic kidney disease, reduces proteinuria, protects podocytes and prevents glomerulosclerosis and mesangial cell proliferation. Sparsentan has been granted Orphan Drug Designation for the treatment of FSGS and IgAN in the U.S. and Europe.
Sparsentan is currently being evaluated in the pivotal Phase 3 DUPLEX Study for the treatment of focal segmental glomerulosclerosis (FSGS) and the pivotal Phase 3 PROTECT Study for the treatment of IgAN. In February 2021, the Company announced that the ongoing DUPLEX Study of sparsentan in FSGS achieved its pre-specified interim FSGS partial remission of proteinuria endpoint (FPRE) with statistical significance. FPRE is a clinically meaningful endpoint defined as urine protein-to-creatinine ratio (UP/C) ≤1.5 g/g and a >40 percent reduction in UP/C from baseline. After 36 weeks of treatment, 42.0 percent of patients receiving sparsentan achieved FPRE, compared to 26.0 percent of irbesartan-treated patients (p=0.0094). Preliminary results from the interim analysis suggest that at the time of the interim assessment, sparsentan had been generally well-tolerated and shown a comparable safety profile to irbesartan. In August of 2021, the Company announced that the ongoing PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than threefold reduction of proteinuria from baseline after 36 weeks of treatment, compared to the active control irbesartan (p