Skip to main content
Which information about ASPAVELI® are you looking for today?

The first and only approved treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) 

in patients 12 years of age and older.1-4

Aspaveli is a targeted C3 and C3b therapy that is designed to regulate excessive activation of C3, a core component of the immune complement system, in adults and adolescents with C3G or primary IC-MPGN.1,2

Explore the disease mechanisms

Target icon

TARGET

Aspaveli® directly targets C31,2,5-10

explore Targeted MoA

Clear icon

CLEAR

ONLY Aspaveli® defuses C3 dysregulation and reduces glomerular C3 accumulation1,2,5-9

review efficacy data

Preserve icon

PRESERVE

Aspaveli® helps to preserve renal function1,2

efficacy

Is time running out for your C3G & IC-MPGN patients’ kidneys?

unmet need
Aspaveli burning fuse gif

Download the results of the pivotal VALIANT study here

VALIANT Study
PDF 0.7 MB 8 Apr 2026
1 pixel spacer
Aspaveli product logo with new endline

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.1

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;  IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; RAS, renin-angiotensin system.

Footnotes

*vs placebo. VALIANT was a phase 3, double-blind, placebo-controlled trial involving adolescents and adults with C3 glomerulopathy or primary immune-complex MPGN, including those with native kidney disease and those with disease recurrence after transplantation. Patients were randomly assigned in a 1:1 ratio to receive pegcetacoplan or placebo. The primary end point was the log-transformed ratio of the urinary protein-to-creatinine ratio at week 26 as compared with baseline.2

References

  1. Aspaveli EMA Summary of product characteristics. Swedish Orphan Biovitrum AB (publ) January 2026.

  2. Fakhouri F, et al. N Engl J Med 2025;393:2210–20. 

  3. FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older. Press Release, 28 July 2025. Available at: https://investors.apellis.com/news-releases/news-release-details/fda-approves-apellis-empavelir-pegcetacoplan-first-c3g-and Accessed April 2026

  4. Sobi Receives European Commission Approval for Aspaveli®(pegcetacoplan) for the Treatment of C3G and Primary IC- MPGN. Press Release, 16 January 2026. Available at: https://www.sobi.com/en/press-releases/sobi-receives-european-commission-approval-aspavelir-pegcetacoplan-treatment-c3g-and-primary-ic-mpgn-2418695. Accessed April 2026. 

  5. Simon-Tillaux N, et al. Presented at American Society of Nephrology Kidney Week 2019, Washington DC, USA; 7–9 November. Poster SA-PO609.

  6. Bomback AS, et al. Kidney Int Rep 2025;10:87–98.

  7. Dixon B, et al. Kidney Int Rep 2023;8:2284–93.

  8. Hoy SM. Drugs 2021;81:1423–30. 

  9. Avest M, et al. Ann Hematol. 2024;103(7):2267–72.

  10. Zwarthoff SA, et al. Front Immunol 2018:9:1691.

This website contains information based on the ASPAVELI® Summary of Product Characteristics as approved by European Commission. License conditions vary between countries. Please consult your local Summary of Product Characteristics or Prescribing Information.
 

PP-32035