Sobi receives European Commission approval for Aspaveli (pegcetacoplan) for the treatment of C3G and primary IC-MPGN

Sobi announced that the European Commission (EC) has approved Aspaveli (pegcetacoplan) 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. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in December 2025. Aspaveli is a targeted C3/C3b inhibitor designed to regulate excessive complement activation, a key driver of C3G and primary IC-MPGN. These conditions are associated with progressive kidney damage and limited treatment options.

“The European Commission approval 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 progression to kidney failure,” said Dr. Lydia Abad-Franch, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. “This approval is underpinned by robust clinical evidence from the VALIANT trial, which demonstrated that pegcetacoplan is able to preserve kidney function by reducing proteinuria, stabilising eGFR and clearing C3 deposits. Aspaveli is now available for patients 12 years and older with these serious conditions. It is the first approved therapy for adolescent patients (12 to 17 years) and the first treatment indicated for primary IC-MPGN.”

This approval is based on positive results from the Phase III VALIANT study, in which Aspaveli demonstrated benefits across the three key markers of disease, including significant reduction in proteinuria, stabilisation of kidney function, and substantial clearance of C3 deposits. These positive results were recently published in The New England Journal of Medicine.

Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.

See- Fakhouri F,  Bomback AS et al.Trial of Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN. N Engl J Med 2025;393:2210 DOI: 10.1056/NEJMoa250151