Summary
Sobi has received European Commission approval for ASPAVELI (pegcetacoplan) to treat C3G and primary IC-MPGN, two rare, progressive kidney diseases.
The approval follows a positive CHMP opinion (December 2025) and marks the first approved treatment for primary IC-MPGN and the first for both C3G and IC-MPGN across adolescents and adults (aged ≥12 years).
Approval is supported by data from the Phase 3 VALIANT trial (NCT05067127), the largest and first global study assessing efficacy and safety across pediatric, adult, and post-transplant groups.
Swedish Orphan Biovitrum (Sobi) has achieved a significant regulatory milestone with the European ...
