Sobi has received European Commission approval for Aspaveli (pegcetacoplan) to treat patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
The therapy is approved in combination with a renin–angiotensin system (RAS) inhibitor, unless RAS treatment is contraindicated or not tolerated.
Aspaveli is a targeted C3/C3b inhibitor designed to control excessive complement activation, a central driver of both diseases.
Key approval highlights:
The approval follows a positive CHMP opinion in December 2025.
The decision is supported by results from the Phase 3 VALIANT study, recently published in The New England Journal of Medicine.
Aspaveli demonstrated benefits across all major disease markers:
The VALIANT trial enrolled 124 patients aged 12 years and older, including adults, adolescents, and post-transplant patients.
C3G and primary IC-MPGN are rare, progressive kidney diseases.
Disease burden remains severe:
Aspaveli directly targets the underlying disease mechanism, rather than only managing symptoms.
Aspaveli (also marketed as Empaveli in some regions) is now approved for C3G and IC-MPGN in:
The drug is also approved for paroxysmal nocturnal haemoglobinuria (PNH).
Sobi and Apellis Pharmaceuticals hold global co-development rights for systemic pegcetacoplan. Sobi manages ex-US commercialisation, while Apellis retains US rights.
Sobi is a global biopharma company focused on rare diseases, with approximately 1,900 employees worldwide.
The company continues to expand its portfolio by targeting high-unmet-need conditions with mechanism-driven therapies.