Travere’s Sparsentan Faces Slower Uptake Due To Liver Monitoring Requirement

Travere Therapeutics, Inc. is facing a delayed approval for sparsentan in immunoglobin A (IgA) nephropathy and will now require liver monitoring, based on late-cycle review interactions with the US Food and Drug Administration. While this is expected to slow uptake, the company is counting on the significant need for new treatment to ensure commercial success. However, it is uncertain whether sparsentan’s nearest competitor will have the same requirements.

Travere said on 13 October that it expects the target action date of 17 November to move back by three months, and that the FDA had requested increased education for physicians and liver monitoring to be added to a risk evaluation and mitigation strategy (REMS), in addition to the already planned REMS program for potential birth defects