Swedish biopharmaceutical company Sobi (STO: SOBI) said on Friday that the European Commission has approved Aspaveli (pegcetacoplan) for use in adults and adolescents aged 12 to 17 with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to be given alongside a renin-angiotensin system inhibitor when clinically appropriate.

C3G and primary IC-MPGN are associated with progressive kidney damage, with more than half of patients developing kidney failure within five to 10 years of diagnosis, requiring either kidney transplant or dialysis therapy. Aspaveli is the first approved treatment for primary IC-MPGN and the first therapy for both conditions in patients aged 12 years and older, addressing diseases which affect around 8,000 people in Europe and 5,000 people in the United States.

The approval decision follows a positive opinion from the Committee for Medicinal Products for Human Use in December 2025 and is based on results from the Phase 3 VALIANT study, which showed reductions in proteinuria, stabilisation of kidney function and clearance of C3 deposits.

Sobi and its partner, US-based biotechnology company Apellis Pharmaceuticals, Inc. (NASDAQ: APLS), hold global co-development rights for systemic pegcetacoplan.