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

Firm Thinks Unmet Need Will Ensure Commercial Success

 
• By Alaric DeArment

The FDA required an updated REMS for liver monitoring out of caution over potential liver toxicity, though the drug has not caused drug-induced liver injury in development to date.

Travere said its PDUFA date for sparsentan, originally 17 November, would be extended by three months • Source: Shutterstock

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...

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