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Aspaveli® resulted in meaningful proteinuria reduction irrespective of IS status1

Pre-specified subgroup analysis at Week 26

IS-TREATED

Relative reduction in Aspaveli® vs placebo:

70.3%

95% CI: 58.3-78.8 (p<0.0001 nominal)1,2

NON IS-TREATED

Relative reduction in Aspaveli® vs placebo:

64.5%

95% CI: 36.6-80.1 (p=0.0005 nominal)1,2
Change in proteinuria (Week 26 vs baseline)1
Aspaveli - IS Status - Change in proteinuria - Week 26 vs baseline
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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; FMU, first-morning spot urine; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; IS, immunosuppressant; LSM, least squares mean; RAS, renin-angiotensin system; uPCR, urine protein-to-creatinine ratio.

References

  1. Kavanagh D, et al. Presented at ERA Congress 2025, Vienna, Austria; 4–7 June 2025. Abstract 288. 

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

  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