Laura Chico

Anupam Rama

Jason Zemansky

Prakhar Agrawal

Will Soghikian

Arseniy Shabashvili

Gregory Harrison

Liisa Bayko

Mohit Bansal

Sadia Rahman

Tyler Van Buren

Vamil Divan

Yigal Nochomovitz

Alexander Thompson

Alex Thompson

Charles Ndiaye

Dina Ramadan

Ed Arce

Farzin

Farzin Haque

Frances Dovell

Greg Wiesner

Joe Thomas

Joseph Schwartz

Joseph Thomas

Maurice Raycroft

Maury Raycroft

Reena

- Travere Therapeutics announced the **FDA approved a modification to the REMS** (Risk Evaluation and Mitigation Strategy) for **FILSPARI**, removing embryofetal toxicity and pregnancy testing requirements, and changing liver function testing from monthly to **quarterly**.  **[1438533_tx_372958_0]**  This change is expected to broaden the patient population, particularly for those with lower proteinuria levels, which represent **70% of the addressable market**.  **[1438533_tx_372958_0]** **[1438533_tx_372958_4]** 
- The company anticipates the upcoming KDIGO guidelines will further reinforce FILSPARI's positioning, driving the urgency for earlier intervention and full remission in IgA nephropathy patients.  **[1438533_tx_372958_2]** **[1438533_tx_372958_4]** 
- For the FSGS program, the FDA is reviewing the sNDA for sparsentan, with an advisory committee review expected.  **[1438533_tx_372958_8]**  Analysis of the DUPLEX study showed that patients achieving partial or complete remission experienced a **67% to 77% reduction in the risk of hard kidney failure endpoints** within two years.  **[1438533_tx_372958_9]** **[1438533_tx_372958_10]** 
- Travere Therapeutics is on track to **reinitiate enrollment next year** for the Phase 3 study of **pegtibatinase** for classical homocystinuria (HCU), following resolution of manufacturing scale-up challenges.  **[1438533_tx_372958_11]**

Travere Therapeutics Details Recent FDA REMS Approval for FILSPARI and Pipeline Progress

- Travere Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved updated **Risk Evaluation and Mitigation Strategy (REMS) labeling** for FILSPARI® (sparsentan) in IgA nephropathy (IgAN).  **[1438533_0c9c608b0f7347a6a9e264ab11a620a0_0]** 
- The approved modification **reduces the frequency of liver function monitoring** for FILSPARI from monthly to **every three months** and **removes the embryo-fetal toxicity monitoring requirement** from the REMS.  **[1438533_0c9c608b0f7347a6a9e264ab11a620a0_0]** 
- These changes were supported by **safety data** from post-marketing surveillance and clinical studies, reflecting the strong safety profile of FILSPARI and aiming to **simplify patient access**.  **[1438533_0c9c608b0f7347a6a9e264ab11a620a0_0]** 
- A supplemental New Drug Application (sNDA) for FILSPARI in focal segmental glomerulosclerosis (FSGS) is currently under FDA review, with a **Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026**.  **[1438533_0c9c608b0f7347a6a9e264ab11a620a0_0]**

Travere Therapeutics Receives FDA Approval for FILSPARI REMS Modification

Travere Therapeutics (TVTX)