Sobi, a biopharmaceutical company advancing innovative therapies for rare diseases, 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). The therapy is approved for use in combination with a Renin-Angiotensin System (RAS) inhibitor, unless RAS treatment is contraindicated or not tolerated.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued in December 2025. Aspaveli is a targeted C3/C3b inhibitor designed to regulate excessive complement activation, a central driver of disease progression in both C3G and primary IC-MPGN rare kidney disorders associated with progressive renal damage and limited treatment options.

Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi, said, “This European Commission approval represents an important milestone for patients living with C3G and primary IC-MPGN, two severe and rare kidney diseases with a high risk of kidney failure. Aspaveli is now available for patients aged 12 years and older and is the first approved therapy for adolescents and the first treatment indicated for primary IC-MPGN.”

The decision is supported by positive data from the Phase III Valiant trial, the largest study conducted in patients with C3G and primary IC-MPGN. The trial demonstrated that pegcetacoplan significantly reduced proteinuria, stabilised kidney function as measured by eGFR, and cleared C3 deposits key markers of disease activity. 

C3G and primary IC-MPGN affect approximately 8,000 patients in Europe, with more than half progressing to kidney failure within five to ten years of diagnosis. Many patients ultimately require dialysis or kidney transplantation, and disease recurrence occurs in up to 90 percent of transplant recipients.