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Paroxysmal nocturnal hemoglobinuria (PNH) is characterized by intravascular hemolysis, anemia, and thrombotic events due to uncontrolled complement system activation. Eculizumab is a humanized monoclonal antibody that blocks terminal complement C5 activation but requires biweekly dosing. Ravulizumab is a new, more potent complement inhibitor with a longer half-life.
To compare the safety and efficacy of ravulizumab with eculizumab, two groups of investigators conducted an industry-sponsored, open-label, randomized, phase III studies, the first involving 246 complement inhibitor–naive patients, and the second involving 195 patients previously treated with eculizumab. In both studies, intravenous doses of ravulizumab were given every 8 weeks a…