Sobi Announces CHMP's Positive Opinion For Aspaveli

rttnews
2025.12.12 13:33
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Sobi announced that the European Medicines Agency's CHMP has given a positive opinion for the marketing authorisation of Aspaveli (pegcetacoplan) for treating C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. The decision is based on Phase 3 VALIANT study results, with European Commission approval expected in Q1 2026. Sobi and Apellis Pharmaceuticals have global co-development rights for the drug.