Travere Therapeutics Announces Plans to Seek Traditional Approval of FILSPARI for Focal Segmental Glomerulosclerosis
Travere Therapeutics, a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with rare diseases, recently announced that it has completed a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its plan to submit a supplemental New Drug Application (sNDA) for FILSPARI, a potential treatment for focal segmental glomerulosclerosis (FSGS).
What is Focal Segmental Glomerulosclerosis (FSGS)?
FSGS is a rare kidney disorder that is a leading cause of kidney failure. It is characterized by scarring in the kidneys, which can result in decreased function and, ultimately, kidney failure. FSGS can affect people of all ages and ethnicities, but it is more common in African Americans and Asians.
About FILSPARI
FILSPARI is an investigational drug developed by Travere Therapeutics that has shown promise in treating FSGS. The sNDA submission will be based on the results from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGS. These studies demonstrated that FILSPARI significantly reduced proteinuria, or the amount of protein in the urine, in patients with FSGS.
Timeline and Next Steps
Travere Therapeutics expects to submit the sNDA around the end of the first quarter of 2025. The Company has also announced that it will host a conference call and webcast today at 8:30 a.m. ET to discuss the FDA meeting and the plans for the sNDA submission.
Impact on Patients and the World
If approved by the FDA, FILSPARI could be the first and only approved medicine indicated for FSGS. This would be a significant milestone for the rare disease community, as there are currently no FDA-approved treatments for FSGS. It could also provide hope for the thousands of patients living with this debilitating disorder.
Beyond the impact on individual patients, approval of FILSPARI could also have a broader impact on the healthcare system. FSGS is a leading cause of kidney failure, and the associated healthcare costs are significant. According to the National Kidney Foundation, the cost of end-stage kidney disease treatment in the United States alone is estimated to be over $30 billion per year.
Conclusion
The completion of the Type C meeting between Travere Therapeutics and the FDA is an important step forward in the development of FILSPARI as a potential treatment for FSGS. If approved, FILSPARI could provide a much-needed therapeutic option for patients with this rare and debilitating kidney disorder. The sNDA submission, which is expected to be made around the end of the first quarter of 2025, will be closely watched by the rare disease community and the healthcare industry as a whole.
- Travere Therapeutics has completed a Type C meeting with the FDA regarding plans to submit an sNDA for FILSPARI to treat FSGS
- The sNDA will be based on the results from Phase 3 DUPLEX and Phase 2 DUET studies
- FSGS is a rare kidney disorder that is a leading cause of kidney failure
- If approved, FILSPARI could be the first and only FDA-approved treatment for FSGS
- The impact on individual patients and the healthcare system could be significant
- Travere Therapeutics will host a conference call and webcast today at 8:30 a.m. ET to discuss the FDA meeting and the plans for the sNDA submission
