Research & Development
Japanese ministry approves extension of Alexion Pharmaceuticals' SOLIRIS marketing authorisation
26 November 2019 -

Japan's Ministry of Health, Labour and Welfare has approved the extension of the present marketing authorisation for United States-based Alexion Pharmaceuticals' SOLIRIS to include the prevention of relapse in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica, it was reported yesterday.

The SOLIRIS approval was based on comprehensive results from the Phase three randomised, 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.

The product was approved for the treatment of NMOSD in adult patients who are anti-AQP4 antibody-positive by the United States Food and Drug Administration (FDA) in June 2019 and by the European Commission (EC) in August 2019. The product received Orphan Drug Designation for the treatment of NMOSD in the US, EU and Japan.