Filspari (sparsentan)
- Region
- 🇪🇺 EU
- Active substance
- sparsentan
- Company
- Vifor France
- Status
- Authorised
- Therapeutic area
- Glomerulonephritis, IGA
- CHMP opinion
- Thu 22 Feb 2024
- EU approval
- Fri 19 Apr 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005783
- ATC
- C09XX01
- Official record
- www.ema.europa.eu
Indication
Filspari is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion > 1.0 g/day (or urine protein-to-creatinine ratio > 0.75 g/g, see section 5.1).
Regulatory milestones
Filspari: PDUFA target action date (focal segmental glomerulosclerosis (FSGS))
Ligand Pharmaceuticals Inc (LGND); sparsentan; sNDA; status: extended; "The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026."; filed 2026-02-26 · source
FILSPARI: PDUFA target action date (Focal segmental glomerulosclerosis (FSGS))
Travere Therapeutics, Inc. (TVTX); sparsentan; sNDA; status: set; "net product sales of FILSPARI totaled $322 million for full year 2025; total net product sales were $410 million for full year 2025 PDUFA target action date for FILSPARI in FSGS is April 13, 2026; Company positioned for a successful commercial launch, if approved Enrollment activities have resumed for the pivotal…"; filed 2026-02-19 · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.