Japan’s Ministry of Health, Labour and Welfare approved Enspryng to treat adults and children with neuromyelitis optica spectrum disorder, according to a press release.
Enspryng (satralizumab, Roche) is approved for the prevention of neuromyelitis optica spectrum disorder (NMOSD) relapses in adults and children who are aquaporin-4 antibody seropositive. In two pivotal phase 3 studies, the drug showed efficacy and significantly reduced the risk for relapse. It was evaluated as monotherapy and as an addition to baseline immunosuppressant therapy.
“Today’s approval in Japan is