(RTTNews) - Sobi (SOBI.ST) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli or pegcetacoplan for the treatment of adult and adolescent patients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis. The CHMP recommendation is based on positive results from the Phase 3 VALIANT study.
The company said the approval decision by European Commission is expected in the first quarter of 2026. Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.
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