FDA Declines Travere’s Second Attempt at Accelerated Approval for Sparsentan

The FDA has rejected Travere Therapeutics’ application for accelerated approval of its investigational drug sparsentan for treatment of patients with focal segmental glomerulosclerosis, a rare disease that affects the kidneys.

This is the second time the agency has denied the company’s request for accelerated approval of this specific drug. The first rejection occurred in May 2021.

The initial rejection was because of inadequate interim data from a phase 3 study. This time around, even with the additional data, the FDA said the data was not enough to support an accelerated approval.

However, the FDA recommended that the company pursue a regular approval pathway for the drug. The company plans to submit a New Drug Application for this indication in the second half of 2023.