Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS
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Travere Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for FILSPARI® (sparsentan) to treat FSGS, a rare kidney condition. If approved, it would be the first FDA-approved treatment for FSGS. The submission is based on positive results from Phase 3 and Phase 2 studies.
March 17, 2025 | 11:15 am
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POSITIVE IMPACT
Travere Therapeutics has submitted an sNDA for FILSPARI® to the FDA, seeking approval for treating FSGS. If approved, it would be the first FDA-approved treatment for this condition, potentially boosting the company's market position.
The submission of an sNDA for FILSPARI® to treat FSGS is a significant step for Travere Therapeutics. If approved, it would be the first FDA-approved treatment for this rare condition, likely leading to increased market share and revenue. The removal of REMS monitoring for embryo-fetal toxicity also reduces regulatory hurdles, further supporting a positive outlook.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100