Enspryng approved in Japan for neuromyelitis optica spectrum disorder
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 the first for Enspryng in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in the release. “Japan has a high prevalence of NMOSD in both adults and children but limited approved treatment options. Enspryng offers robust efficacy, is well-tolerated, and is the first and only approved therapy targeting the interleukin-6 receptor given subcutaneously every 4 weeks.”
Enspryng was previously approved in Canada as monotherapy as well as an add-on therapy. Marketing applications were accepted by the European Medicines Agency and the FDA in October 2019, with both agencies expected to announce decisions later this year.