Aspaveli Receives CHMP Green Light: A Positive Move on Quotes for Sobi's Pipeline

Sobi has reached a significant milestone in its clinical development portfolio. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a favorable assessment, endorsing the marketing authorisation for Aspaveli, a therapeutic agent known as pegcetacoplan. This recommendation targets treatment options for adult and adolescent patients suffering from C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis.

The regulatory backing stems from robust clinical evidence gathered during Phase 3 VALIANT study, which demonstrated efficacy and safety profiles supporting the drug’s therapeutic utility. The trajectory toward full approval appears well-defined, with the European Commission anticipated to render its formal decision during the opening quarter of 2026.

This collaborative advancement reflects the combined efforts of Sobi and partner Apellis Pharmaceuticals, Inc., who jointly hold global co-development rights for systemic pegcetacoplan applications. The partnership structure positions both entities to benefit from the drug’s market entry across international territories.

The CHMP’s positive recommendation represents a constructive progression through the European regulatory framework, bringing the therapeutic option closer to patients in need while validating the clinical development pathway undertaken by the sponsoring organizations.