Roche?s ENSPRYNG (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder
ENSPRYNG is Japan?s first and only approved therapy for both adults and children with neuromyelitis optica spectrum disorder (NMOSD)
- ENSPRYNG is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks
- Approval is supported by data demonstrating ENSPRYNG?s robust efficacy, which was well-tolerated with a consistent safety profile, in a broad NMOSD population as a monotherapy and as an add-on therapy
- Asia has a high prevalence of NMOSD with limited treatment options
- In the overall population, a reduction in the risk of relapse was observed in both pivotal studies:
- In SAkuraSky, the risk of relapse was reduced by 62% (HR, 0.38; 95% CI, 0.16?0.88; p=0.0184) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
- In SAkuraStar, the risk of relapse was reduced by 55% (HR, 0.45; 95% CI, 0.23?0.89; p=0.0184) with ENSPRYNG monotherapy, compared to placebo
- In the pre-specified subgroup of AQP4-IgG seropositive patients, a reduction in the risk of relapse was observed in both pivotal studies:
- In SAkuraSky, the risk of relapse was reduced by 79% (HR, 0.21; 95% CI, 0.06?0.75) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
- In SAkuraStar, the risk of relapse was reduced by 74% (HR, 0.26; 95% CI, 0.11?0.63) with ENSPRYNG monotherapy, compared to placebo
- Overall, the proportion of patients with serious adverse events was similar between the ENSPRYNG and placebo groups in both studies. A lower rate of infections (including serious infections) was observed in patients treated with ENSPRYNG compared with the placebo group. The safety profile in longer term follow up is consistent with the double-blind period.
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