Genentech will present new Enspryng™ (satralizumab-mwge) 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 in addition to longer-term efficacy data supporting the continued effect of Enspryng on reducing the risk of NMOSD relapse, as well as its favorable benefit-to-risk profile.
In a post-hoc analysis of the Enspryng-treated group, the risk of severe relapse was reduced by 79% compared to placebo 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 treatment management. The patients treated with Enspryng were also less likely to require rescue therapy for a relapse compared with placebo.
“The longer-term data for Enspryng further reinforce the previously observed efficacy of this medicine for this debilitating disorder that is often mistaken for multiple sclerosis,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Enspryng is the first and only FDA-approved subcutaneous, self-administered medicine for NMOSD and the first medicine for NMOSD that is designed to target the interleukin-6 receptor, which is believed to play a key role in the inflammation associated with this disorder.”
Enspryng is approved in Canada, Japan, Switzerland and the U.S. Additional applications are under review with numerous regulators, including in the EU and China. Enspryng has been designated as an orphan drug in the U.S., Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.
SAkuraStar is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng monotherapy administered to patients with NMOSD. Study results were published in the May 1, 2020 edition of The Lancet Neurology. SAkuraSky is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng added to baseline immunosuppressant therapy in patients with NMOSD. Results were published in the November 28, 2019 edition of the New England Journal of Medicine (NEJM).
Full press release: https://www.gene.com/media/press-releases/14879/2020-09-09/new-data-show-genentechs-enspryng-signif