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Change in proteinuria (baseline to Week 52)1
Aspaveli - proteinuria at 52 weeks

 

Change in eGFR (baseline to Week 52)
Aspaveli - change in eGFR at 52 weeks

Change in eGFR from baseline improved from -7.8 at 26 weeks with placebo to -4.7mL/min/1.73 m2 at 52 weeks after switching to Aspaveli®1,2

 

eGFR remained stable over 52 weeks with Aspaveli, while patients switching from placebo showed stabilization after entering the open-label Aspaveli period1,2

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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; CI, confidence interval; eGFR, estimated glomerular filtration rate; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; LSM, least squares mean; RAS, renin-angiotensin system; uPCR, urine protein-to-creatinine ratio.

References
  1. Fakhouri F, et al. Abstract presented at ERA Congress 2025, Vienna, Austria; June 4–7 2025. Abstract 77.

  2. Nester CM, et al. Presented at American Society of Nephrology Kidney Week 2024, San Diego, USA; 23–27 October 2024. Oral SA-OR92.

  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