Apellis and Sobi Report New Data Reinforcing the Robust Efficacy and Safety Profile of EMPAVELI® (pegcetacoplan) for PNH at EHA 2022 Congress

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[{"type":"text","content":"WALTHAM, Mass. and STOCKHOLM, Sweden, June 10, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today reported new analyses of Phase 3 studies that reinforce the robust efficacy and safety profile of EMPAVELI®/Aspaveli® (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria (PNH). The data will be presented at the hybrid European Hematology Association (EHA) Congress in Vienna, Austria. New analyses demonstrated that treatment with EMPAVELI resulted in meaningful improvements in quality of life for treatment-naïve patients and suggested the incidence of thrombosis was comparable to eculizumab, a C5 inhibitor. Additionally, a matching-adjusted indirect comparison (MAIC) showed significant improvements in clinical outcomes in treatment-naïve patients who received EMPAVELI compared to C5 inhibitors. “The data presented at EHA add to a growing body of evidence, which shows that EMPAVELI leads to both clinically meaningful efficacy and improved quality of life regardless of prior treatment,” said Peter Hillmen, M.B. Ch.B., Ph.D., head of hematology engagement at Apellis. “Many patients experience a significant disease burden, even with C5 inhibitor treatment, so these data further emphasize that EMPAVELI has the potential to become a new standard of care for PNH.” “We are very pleased that these new data further reinforce the safety and efficacy of EMPAVELI/Aspaveli in treating such a rare, chronic, and life-threatening condition,” said Anders Ullman, head of research and development and chief medical officer at Sobi. “Sobi and Apellis are firmly committed to improving the care and quality of life for those affected by this rare blood disease.” EMPAVELI Demonstrated Meaningful Improvements in Quality of Life in Treatment-Naïve Patients In an analysis of the Phase 3 PRINCE study, EMPAVELI patients who were previously treatment-naïve demonstrated meaningful quality-of-life improvements through 26 weeks, reaching normal or near-normal levels of the general population. These data, which were assessed using multiple measures including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scale, will be reported during an oral presentation at the congress. Results Suggested Incidence of Thrombosis Comparable across EMPAVELI- and Eculizumab-Treated Pat...

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