Travere Expecting 3-month NDA Review Extension

Travere Therapeutics is expecting FDA to extend by three months its review of an accelerated approval-seeking NDA for sparsentan and its use in treating IgA nephropathy. “As part of its late-cycle review, the FDA has 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, adding that it expects to do so in coming days.

“Based upon feedback from the FDA, the updated 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 target action date to allow sufficient time to review the information,” the company says. “No additional clinical data or studies have been requested as part of the application review process.”