New PDUFA target action date is April 13, 2026
Commercial launch preparations continue in anticipation of potential approval
Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026.
The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit of FILSPARI. The FDA determined that the additional responses constituted a Major Amendment (MA) to the sNDA and extended the action date accordingly. No additional information relating to the safety or manufacturing of FILSPARI has been requested.
“We believe in the potential of FILSPARI to make a meaningful difference in the lives of people living with FSGS and are encouraged by the productive engagement with the FDA,” said Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics. “We remain focused on the goal of bringing FILSPARI to the patients who urgently need an effective medicine for this devastating and rapidly progressing disease and remain committed to working with the Agency during the extension period. In parallel, our commercial preparations continue to ensure a successful launch, if approved.”
If approved, FILSPARI would be the first medication indicated for FSGS, a rare and serious kidney disorder driven by proteinuria that leads to progressive kidney function loss and kidney failure. FILSPARI is an oral, non-immunosuppressive potential therapy that targets podocyte injury, a key driver of FSGS progression.
FILSPARI is fully approved by the FDA and European Medicines Agency (EMA) to slow kidney function decline in adults with IgA nephropathy.
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