Lancet Neurology Publishes Pivotal Phase 3 Data for Genentech’s Satralizumab for NMOSD

Source: Genentech

Lancet Neurology published full pivotal phase 3 clinical data on investigational medicine satralizumab as a monotherapy for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease that is commonly misdiagnosed as multiple sclerosis. The full manuscript can be found online here.

Data from the SAkuraStar study show the following:

  • 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 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.  
  • 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
  • Unlike other NMOSD medicines, satralizumab can be self-administered as a subcutaneous injection every 4 weeks.

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. More approved treatment options are needed for this underserved population, and the FDA has accepted Genentech’s BLA application for satralizumab, with a decision expected later this year. 

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