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The safety profile in adolescents in VALIANT appeared consistent with the overall population2

TEAE frequency and severity were similar between treatment groups for the adolescent population.

  • 23 adolescents (82.1%) in the Aspaveli® arm and 26 (96.3%) in the placebo arm experienced TEAEs 
  • Serious TEAEs occurred in 3 adolescents in each treatment group (Aspaveli®, 10.7%; placebo, 11.1%) 
  • In the Aspaveli® arm, 1 serious TEAE (pyrexia) was considered related to treatment 

Health shield

  • At 26 weeks, no TEAEs led to study discontinuation
  • No TEAEs led to death
  • No graft loss or rejection in post-transplant patients
  • No serious infections caused by encapsulated bacteria
  • No cases of encapsulated meningococcal infections reported1 
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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.2

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

AE, adverse event; C3, complement 3; C3G, C3 glomerulopathy; IC-MPGN, immune complex-mediated membranoproliferative glomerulonephritis; RAS, renin-angiotensin system; TEAE, treatment-emergent adverse event. 

References

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

  2. 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-32966