Travere therapeutics submits snda to fda for approval of filspari® (sparsentan) for the treatment of fsgs

Snda submission based on results from phase 3 duplex and phase 2 duet studies of filspari in fsgs if approved, filspari could become the first and only fda-approved treatment for fsgs, a rare kidney condition and a leading cause of kidney failure additionally, the fda notified the company that rems monitoring for embryo-fetal toxicity is no longer necessary; the company plans to submit an amendment to the rems snda currently under review for modification of liver monitoring san diego, march 17, 2025 (globe newswire) -- travere therapeutics, inc., (nasdaq: tvtx) today announced the company has submitted a supplemental new drug application (snda) to the u.s. food and drug administration (fda) seeking priority review for traditional approval of filspari® (sparsentan) for the treatment of focal segmental glomerulosclerosis (fsgs). the submission is supported by results from the phase 3 duplex study and the phase 2 duet study, two of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with fsgs.
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