Posted by Michael Wonder on 28 Aug 2019
European Commission approves Soliris (eculizumab) for the treatment of adults with neuromyelitis optica spectrum disorder
27 August 2019 - 98% of adult anti-aquaporin-4 antibody-positive patients treated with Soliris were relapse free compared to 63% receiving placebo at 48 weeks.
Alexion Pharmaceuticals today announced that the European Commission (EC) has approved the extension of the current marketing authorisation of Soliris (eculizumab) to include the treatment of neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody-positive with a relapsing course of the disease.
The EC approval is based on comprehensive results from the Phase 3 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.
