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Proportion of patients achieving ≥50% proteinuria reduction (Week 26 vs baseline)1,2 
Aspaveli - proteinuria reduction vs placebo

Key secondary endpoint

Odds ratio Aspaveli® vs placebo

31x higher odds of achieving ≥50% proteinuria reduction p<0.0011,2
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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.3

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

* p<0.001 based on logistic regression or hypothesis testing for the odds ratio.1

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

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

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

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-32965