| Current KDIGO guidelines recommend options that only help manage symptoms2-4 |
The KHI expert consensus on clinical endpoints in C3G states that efficacy for complement pathway-targeting treatment requires a favourable effect on three endpoints:8
We need a treatment that achieves CONVINCING EFFICACY on all THREE ENDPOINTS from the KHI expert consensus8,9
RaDaR, GLOSEN and Ghadder et al10-12 identifed >50% proteinuria reduction as a key marker for reducing the risk of progression to kidney failure.
EMA indication:
ASPAVELI® is indicated for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated.13
| For the full EMA Aspaveli SmPC, please click here |
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via their national pharmacovigilance reporting system. Suspected adverse reactions should also be reported to Sobi via email at [email protected].
Abbreviations
C3, complement 3; C3G, C3 glomerulopathy; eGFR, estimated glomerular filtration rate; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; KHI, Kidney Health Initiative; RAS, renin-angiotensin system.
References
Halfon M, et al. Kidney Int Rep. 2024;10(1):75–86.
Heidenreich K, et al. Front Nephrol 2024;4:1460146.
Trimarchi H. World J Nephrol. 2017;6(5):221–228.
Kavanagh D, et al. Kidney Int Rep 2026;11:17–31.
Bomback AS, et al. Kidney Int Rep 2024;10(1):17–28.
Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. Kidney Int 2021;100(4S):S1–276.
Heiderscheit AK, et al. Am J Med Genet C Semin Med Genet 2022;190:344–57.
Nester CM, et al. Clin J Am Soc Nephrol 2024;19:1201–8.
Wong E, et al. Kidney Int Rep 2023;8(12):2754–64.
Masoud S, et al. Kidney Int 2025;108(3):455–69.
Caravaca-Fontán F, et al. Nephrol Dial Transplant 2022;37:1270–80.
Ghaddar M, et al. Clin J Am Soc Nephrol 2025;20(8):1119–31.
Aspaveli EMA Summary of product characteristics. Swedish Orphan Biovitrum AB (publ) January 2026.