The journal Lancet Neurology last month published full pivotal Phase III clinical data on investigational medicine satralizumab as a monotherapy for the treatment of neuromyelitis optica spectrum disorder (NMOSD). These data further add to previously reported results for satralizumab in combination with baseline therapy for people with NMOSD, shown in the SAkuraSky clinical trial.
MNOSD is a rare, debilitating central nervous system disease that is commonly misdiagnosed as multiple sclerosis. People with NMOSD experience unpredictable, severe relapses that cause cumulative, permanent, neurological damage and disability—just one relapse may lead to blindness, debilitating motor dysfunction, and in some cases death.
Satralizumab is a humanized monoclonal antibody targeting the interleukin-6 receptor. Satralizumab monotherapy achieved a significant, sustained reduction in the risk of relapse compared to those on placebo in the overall study population, with a higher proportion of patients relapse-free at 48, 96 and 144 weeks. In patients seropositive for anti–aquaporin-4 (AQP4-IgG) antibodies, who tend to experience a more severe disease course, 83%, 77% and 77% of patients on satralizumab were relapse-free at weeks 48, 96 and 144, respectively.
Unlike other NMOSD medicines, satralizumab can be self-administered as a subcutaneous injection every 4 weeks. The FDA has accepted Genentech’s BLA application for satralizumab, with a decision expected later this year.