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# More Data Needed for Travere Accelerated NDA: FDA
- URL: https://www.fdaweb.com/more-data-needed-for-travere-accelerated-nda-fda/
- Published: 2021-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:00:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149410

After a pre-NDA meeting with FDA, Travere Therapeutics says the agency believes that data from the ongoing Phase 3 DUPLEX study of sparsentan for treating focal segmental glomerulosclerosis (FSGS) are not adequate to support accelerated approval. Based on the agency’s feedback, the company no longer expects to submit a sparsentan NDA for accelerated approval for FSGS during the previously planned second half of 2021.

FDA did indicate, according to Travere, that it may be possible to submit an application for accelerated approval after additional data accrue in the study. “Subject to further discussion with the FDA, the company believes that it may be possible to provide sufficient additional estimated glomerular filtration (eGFR) data from the DUPLEX Study in the first half of 2022,” it says. “The FDA has encouraged the company to request a follow-up meeting to further explore this option in greater detail, and a Type A meeting is expected to occur in the third quarter of 2021.”

FSGS is a rare proteinuric kidney disorder that affects about 40,000 patients in the U.S. It is associated with progressive kidney scarring and often leads to end-stage kidney disease, according to the company. FSGS is characterized by proteinuria, where protein leaks into the urine due to a breakdown of the normal filtration mechanism in the kidney.