- ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies.
- Pooled data from SAkura open-label extension (OLE) studies support continued effect of ENSPRYNG reducing risk of relapse in the longer term
- Ongoing data continues to show a favourable safety profile for ENSPRYNG
- ENSPRYNG was recently approved by the U.S. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD
Basel, 10 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) will present new ENSPRYNG® (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020, the 8th joint ACTRIMS-ECTRIMS meeting, in addition to longer-term efficacy data supporting the continued effect of ENSPRYNG on reducing the risk of NMOSD relapse, as well as its favourable benefit:risk profile.
“The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD,” said Professor Anthony Traboulsee, M.D., Neurologist and Professor, University of British Columbia, and Research Chair of the MS Society of Canada. “ENSPRYNG, the first approved treatment for NMOSD that can be taken at home, offers favourable efficacy and safety, which are important for improved long-term outcomes.’’
In a post-hoc analysis of the ENSPRYNG-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies. Preventing relapses, the most severe of which cause cumulative, irreversible, neurological damage and disability, is the primary goal for NMOSD disease management. The patients treated with ENSPRYNG were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, p=0.015). A relapse was categorised as severe if it resulted in a change of ≥2 points on the Expanded Disability Status Scale.