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Sobi Receives European Commission Approval for Aspaveli® (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN
Sobi® (STO: SOBI), today 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
About this update from Swedish Orphan Biovitrum Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"Approximately 8,000 people in Europe are living with C3G or primary IC-MPGN","length":75,"tagName":"p"}]},{"val":[{"type":"text","content":" Aspaveli (pegcetacoplan) is the first treatment of primary IC-MPGN and the first treatment for C3G and primary IC-MPGN for patients 12 years and older","length":150,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":225,"olType":false},{"type":"text","content":"STOCKHOLM, Jan. 16, 2026 /PRNewswire/ -- Sobi® (STO: SOBI), today 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","length":456,"tagName":"p"},{"type":"text","content":"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.","length":349,"tagName":"p"},{"type":"text","content":""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 Lydia Abad-Franch, MD, 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."","length":818,"tagName":"p"},{"type":"text","content":"C3G and primary IC-MPGN are rare kidney diseases affecting approximately 8,000 patients in Europe. More than half of people living wi...