Roche’s Enspryng Approved in Canada for Neuromyelitis Optica Spectrum Disorder
Health Canada has authorized Roche’s Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), either as a monotherapy or in combination with immunosuppressive therapy.
The approval was based on results from two phase 3 clinical trials in which Enspryng reduced the risk of relapses for NMOSD patients compared to a placebo. Rates of adverse events were comparable between the two groups.
The FDA approved Enspryng in August as a treatment for adult NMOSD patients with the anti-aquaporin-4 antibody, which is a biomarker for neuromyelitis optica.