Summary
INNOVATIVE NON-IMMUNOSUPPRESSIVE DUAL MoA
FILSPARI, a DEARA, dual endothelin angiotensin receptor antagonist, targets two critical pathways, the endothelin and angiotensin pathways, involved in disease progression in one molecule1
SUPERIOR SUSTAINED PROTEINURIA REDUCTION VS MAXIMUM‑LABELED DOSE IRBESARTAN
Rapid* and significant reduction as early as Week 4, sustained through Week 1102,3†
Consistent treatment effect across subgroups3‡
Patients were 2.5x more likely to reach complete remission vs maximum-labeled dose irbesartan2§
Assessed in the only active‑controlled head‑to‑head trial in IgAN2–4
PRESERVES KIDNEY FUNCTION
Significantly slower rate of eGFR decline2†**
3.7 mL/min/1.73 m2 absolute difference in change in eGFR from baseline to Week 110 (95% CI; 1.5, 6.0)2†
CONVENIENT ONCE-DAILY TABLET
Suitable for chronic use1,2
TEAEs were well-balanced between FILSPARI and irbesartan, except for dizziness and hypotension2††
One tablet, once daily. One molecule addressing two critical pathways involved in IgAN disease progression1
References & footnotes
Footnotes
*An interim analysis was undertaken after the first 280 patients had undergone the Week 36 visit. A significant reduction in UP/C was seen as early as Week 4 and maintained at Week 6, 12, 24, and 36, p<0.0001 at each week until Week 36. The improvement in proteinuria reduction was sustained through Week 1102,3
†vs maximum-labeled dose irbesartan2
‡Subgroups defined by: baseline demographic characteristics such as age, sex, race, geographic region, and baseline BMI; baseline eGFR and UPE; and baseline IgAN and medical history, such as age at IgAN diagnosis, kidney biopsy to time of informed consent, history of hypotension, and baseline use of antihypertensive medications. Consistent treatment effect across subgroups was reported in the prespecified interim analysis at Week 363,5
§Complete proteinuria remission (<0.3 g/day) occured in 31% of patients in the FILSPARI group vs 11% in the irbesratan group, RR 2.5,95% CI, 1.6, 4.12
**Chronic slope. Key secondary endpoints included chronic eGFR slope (rate of eGFR change over Week 6 to Week 110) and total eGFR slope (Day 1–Week 110) over the full double-blind treatment period. Chronic slope for FILSPARI vs maximum-labeled dose irbesartan was -2.7 vs -3.8 mL/min/1.73 m2 per year, respectively; difference, 1.1 mL/min/1.73 m2 per year; 95% CI, 0.1, 2.1; p=0.037. Total slope for FILSPARI vs maximum-labeled dose irbesartan was -2.9 vs -3.9 mL/min/1.73 m2 per year, respectively; difference, 1.0 mL/min/1.73 m2 per year; 95% CI, -0.03, 1.94; p=0.0582
††The efficacy and safety of FILSPARI has been evaluated in PROTECT in patients with IgAN. In PROTECT, adverse events were well-balanced between treatment groups, except for dizziness (15% with FILSPARI vs 6% with irbesartan) and hypotension (13% with FILSPARI vs 4% with irbesartan)2
Abbreviations
BMI, body mass index; CI, confidence interval; DEARA, dual endothelin angiotensin receptor antagonist; eGFR, estimated glomerular filtration rate; IgA, immunoglobulin A, IgAN, immunoglobulin A nephropathy; MoA, mechanism of action; TEAE, treatment-emergent adverse event; UP/C, urine protein-to-creatinine ratio; UPE, urine protein excretion
References
- FILSPARI. EU SmPC. April 2024.
- Rovin B, et al. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial. Lancet. 2023;402(1041):20–90.
- Heerspink HJL, et al. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023;401(10388):1584–94.
- Campbell KN, et al. Practical Considerations for the Use of Sparsentan in the Treatment of Patients with IgAN in Clinical Practice. Int J Nephrol Renovasc Dis. 2023;16:281–91.
- Heerspink HJL, et al. Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial. Lancet. 2023;401(10388):1584–94. [Suppl Appendix].
Filspari is contraindicated during pregnancy. Filspari treatment must only be initiated in women of childbearing potential when the absence of pregnancy has been verified. Women of childbearing potential have to use effective contraception during and up to 1 month after treatment has stopped.
This medicinal product has been granted a conditional marketing authorization by the European Commission.
▼ This medicinal product is subject to additional monitoring. This will allow identification of new safety information. This SmPC may be updated from time to time as necessary. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should also be reported to CSL Vifor at safety@viforpharma.com
Medicinal product subject to restricted medical prescription. Full prescribing information is available on request. Please read the full SmPC prior to administration. Filspari® is a registered trademark.
Vifor France. 100–101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris La Défense Cedex, France
Date of preparation: April 2024 | API job number: HQ-SPT-2400059
HQ-SPT-2500001 | Date of preparation: February 2025