• Approximately 8,000 people in Europe are living with C3G or primary IC-MPGN
• If approved, Aspaveli (pegcetacoplan) would be the first C3G and primary IC-MPGN treatment for patients 12 and older

Sobi® announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli® (pegcetacoplan) for the treatment of adult and adolescent patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

The positive opinion from the CHMP is now referred to the European Commission for an approval decision, which is expected in the first quarter of 2026. Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.

"The CHMP's positive opinion for Aspaveli represents an important milestone for people living with C3G or primary IC-MPGN in Europe, two severe and rare kidney diseases with limited treatment options and a high risk of kidney failure," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. "If approved, Aspaveli would become the first therapy for patients 12 years and older with these serious kidney diseases, which often affect adolescents and young adults. We look forward to the European Commission's decision and to the opportunity to make a meaningful difference in the lives of patients and their families."

C3G and primary IC-MPGN are rare kidney diseases affecting approximately 8,000 patients in Europe. More than half of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy.

The CHMP recommendation is based on positive results from the Phase 3 VALIANT study, in which Aspaveli demonstrated benefits across three key markers of disease, including significant reduction in proteinuria, stabilisation of kidney function, and substantial clearance of C3 deposits.