Drug maker Alexion says that it is preparing for regulatory submissions in the United States, the European Union, and Japan for eculizumab (Soliris) for the treatment of anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.
Alexion studied eculizumab in patients with antibody-positive NMOSD in the phase 3 PREVENT trial, a multinational, double-blind, parallel-group, time-to-event study in 143 patients. The patients were randomized 2 to 1 to receive either eculizumab or placebo, and the primary endpoint was the time to the first on-trial relapse.
The study met its primary endpoint, having demonstrated that treatment with the study drug reduced the risk of relapse by 94.2% versus placebo (P <.0001). At 48 weeks of treatment, 97.9% of patients receiving eculizumab were free of relapse versus 63.2% of patients receiving the placebo.
Eculizumab was generally well tolerated, and its safety profile was consistent with that seen in previous clinical studies and real-world use in other indications. No cases of meningococcal infection—an adverse event of particular concern with eculizumab—were observed.
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