EMA approves Soliris to treat neuromyelitis optica spectrum disorder
Alexion Pharmaceuticals, Inc.announced that the European Commission (EC) has approved the extension of the current marketing authorization of Soliris (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.
The EC approval is based on comprehensive results from the Phase III randomized, double-blind placebo controlled PREVENT trial, which were published in The New England Journal of Medicine and a long-term extension study (ECU-NMO-302), which is still underway.
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