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IN THE VALIANT STUDY ASPAVELI WAS WELL TOLERATED WITH FEW PATIENTS DISCONTINUING TREATMENT2

Treatment-emergent adverse events at week 26 by treatment group*
Aspaveli treatment emergent adverse events

Discontinuation rate due to TEAEs was just 1.6% at week 262

At week 26: The most commonly reported adverse drug reactions (≥1/10 patients) in patients with C3G or primary IC-MPGN treated with Aspaveli were infusion site reactions and upper respiratory tract infections.1

No cases of encapsulated meningococcal infections reported1

Find the detailed population subgroup safety data here

TEAEs to 52 weeks were consistent with the VALIANT study at 26 weeks3

52 weeks

Aspaveli demonstrated a favourable safety profile among adolescents4 

Adolescents

Aspaveli® was well-tolerated in transplanted patients with disease recurrence5

Transplant

Aspaveli® was well-tolerated in IS and non IS-treated patients6

IS status
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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.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; IS, immunosuppressant; RAS, renin-angiotensin system; TEAE, treatment-emergent adverse event. 

Footnotes

*Data are shown for patients in the safety population, which included all the patients who received at least one dose of pegcetacoplan or placebo. Shown are adverse events that emerged or worsened from the first dose up to 56 days after the last dose. Covid-19 denotes coronavirus disease 2019.

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

  4. Mastrangelo A, et al. Presented at ERA Congress 2025, Vienna, Austria; 4–7 June 2025. Abstract 3413. 

  5. Oosterveld M, et al. Poster presented at ERA Congress 2025, Vienna, Austria; 4–7 June 2025. Abstract 3482. 

  6. Kavanagh D, et al. Nephrol Dial Transplant. 2025;40(Suppl 3):gfaf116.020. 

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-32966