FDA REMS request delays Travere kidney drug approval

Oct. 14, 2022

Travere Therapeutics has provided a regulatory update for its kidney disease drug candidate,  sharing that the company expects its mid-Nov. PDUFA date to be extended by three months.

According to San Diego-based Travere, as part of its late-cycle review, the FDA requested that the company update its proposed Risk Evaluation Mitigation Strategy (REMS) to include liver monitoring for sparsentan consistent with certain other approved products in the endothelin receptor antagonist class. Travere says it will submit an updated REMS in the next few days.

The drug in question — sparsentan — is a Dual Endothelin Angiotensin Receptor Antagonist (DEARA) currently being evaluated against two types of rare kidney disease in two phase 3 studies — the DUPLEX study for the treatment of FSGS and the PROTECT study for the treatment of IgAN.

The company was originally given a target action date of Nov. 17 under Subpart H for accelerated approval, however, the updated REMS submission is likely to be considered a major amendment to the NDA which is expected to result in a three-month extension of the PDUFA date to allow sufficient time to review the information. No additional clinical data or studies have been requested as part of the application review process, according to Travere.