Apellis and Sobi announce EU approval of Aspaveli for treatment of paroxysmal nocturnal hemoglobinuria.
Based on the recommendation from the European Medicines Agency’s Committee for Orphan Medicinal Products, the EC determined that pegcetacoplan continues to meet the criteria for the orphan drug designation status granted in 2017 for the treatment of PNH.
The approval is based on the results from the head-to-head PEGASUS Phase III study, which evaluated the efficacy and safety of Aspaveli compared to eculizumab at 16 weeks in adults with PNH who had persistent anaemia despite treatment with eculizumab. The full safety and efficacy results were published in The New England Journal of Medicine in March 2021.
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