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 weeksApproval 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 therapyAsia has a high prevalence of NMOSD with limited treatment options             
Basel, 29 June 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks.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 placeboIn 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 placeboOverall, 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.
About SAkuraStar and SAkuraSky in NMOSD
SAkuraStar is a Phase III multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of ENSPRYNG monotherapy administered to patients with NMOSD. The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. Results from the SAkuraStar study were presented at the 35th  Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in 2019, and were published in The Lancet Neurology in April 2020.Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
– Nicolas Dunant (Head)
– Patrick Barth
– Daniel Grotzky
– Karsten Kleine
– Nathalie Meetz
– Barbara von Schnurbein Attachment29062020_MR_ ENSPRYNG satralizumab approved in Japan_EN