1. Scrip
  2. >>Business
  3. >>Strategy

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...

Welcome to Scrip

Create an account to read this article

Already a subscriber?

More from Strategy

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.

More Players, Better Pricing, Tough Equity Market: Royalty Deals Go Mainstream

 
• By Manas Mishra

Royalty deals are on track for another blowout year, but it’s not only because of a depressed biotech market. Large investment firms such as KKR are taking note.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making forecasting for the pharma industry extremely difficult, Scrip finds in this infographic analysis

S&E In Brief: Launch Trends And Regulatory Updates Among SMID Biopharmas

 
• By Jessica Merrill

Ultragenyx updated investors on interactions with the US FDA on gene therapy, while new drug launches were themes for Ionis and Organon in Q2 reporting.

More from Business

Competition Weighs On Gilead’s CAR-Ts As Both See Sales Decline

 
• By Alaric DeArment

The quarter saw strong growth overall, but the company now expects sales of Yescarta and Tecartus to fall for the full year 2025 versus 2024 thanks to competition.

More Players, Better Pricing, Tough Equity Market: Royalty Deals Go Mainstream

 
• By Manas Mishra

Royalty deals are on track for another blowout year, but it’s not only because of a depressed biotech market. Large investment firms such as KKR are taking note.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making forecasting for the pharma industry extremely difficult, Scrip finds in this infographic analysis