(RTTNews) - Genentech, a member of the Roche Group (RHHBY.PK), on Thursday, announced new longer-term efficacy and safety data for Enspryng (satralizumab-mwge). The data show Enspryng has a favorable benefit-risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD, a rare debilitating disease that affects the central nervous system.
The pivotal SAkuraStar and SAkuraSky four year OLE data found that 73% and 71% of people with AQP4-IgG seropositive NMOSD treated with Enspryng remained relapse-free after 192 weeks, respectively, and 90% and 91% remained free from severe relapse. These results demonstrate that the robust efficacy observed in the studies' double-blind periods is sustained longer-term for Enspryng as both a monotherapy and in combination with immunosuppressive therapy.
Genentech is also initiating SAkuraBONSAI, a multicenter, Phase IIIb, international study, to further evaluate disease activity and progression using comprehensive imaging, biomarker and clinical assessments in NMOSD populations where further research is warranted.
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