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Review
. 2020 Sep;80(14):1477-1482.
doi: 10.1007/s40265-020-01380-2.

Satralizumab: First Approval

Young-A Heo  1
Affiliations
Review

Satralizumab: First Approval

Young-A Heo. Drugs. 2020 Sep.

Erratum in

Abstract

Satralizumab (Enspryng®), a humanized anti-interleukin-6 (IL-6) receptor monoclonal recycling antibody, has been developed by Chugai Pharmaceutical and Roche for the treatment of neuromyelitis optica spectrum disorder (NMOSD). In June 2020, based on positive results from two pivotal phase III trials, subcutaneous satralizumab received its first global approval in Canada for the treatment of NMOSD in adults and children aged ≥ 12 years who are aquaporin 4 water channel autoantibody (AQP4-IgG) seropositive. Satralizumab was subsequently approved in Japan, Switzerland and the USA. Satralizumab is under regulatory review in the EU, and is undergoing clinical development in several countries worldwide. This article summarizes the milestones in the development of satralizumab leading to this first approval for the treatment of NMOSD.

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Conflict of interest statement

Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Figures

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Key milestones in the development of satralizumab BLA Biologics License Application, MAA Marketing Authorization Application, NMO neuromyelitis optica, NMOSD neuromyelitis optica spectrum disorder
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References

    1. Xue T, Yang Y, Lu Q, et al. Efficacy and safety of monoclonal antibody therapy in neuromyelitis optica spectrum disorders: evidence from randomized controlled trials. Mult Scler Relat Disord. 2020 doi: 10.1016/j.msard.2020.102166. - DOI - PubMed
    1. Collongues N, Ayme-Dietrich E, Monassier L, et al. Pharmacotherapy for neuromyelitis optica spectrum disorders: current management and future options. Drugs. 2019;79(2):125–142. doi: 10.1007/s40265-018-1039-7. - DOI - PubMed
    1. Kessler RA, Mealy MA, Levy M. Treatment of neuromyelitis optica spectrum disorder: acute, preventive, and symptomatic. Curr Treat Options Neurol. 2016;18(1):2. doi: 10.1007/s11940-015-0387-9. - DOI - PMC - PubMed
    1. Finke C, Zimmermann H, Pache F, et al. Association of visual impairment in neuromyelitis optica spectrum disorder with visual network reorganization. JAMA Neurol. 2018;75(3):296–303. doi: 10.1001/jamaneurol.2017.3890. - DOI - PMC - PubMed
    1. Araki M, Yamamura T. Neuromyelitis optica spectrum disorders: emerging therapies. Clin Exp Neuroimmunol. 2017;8(2):107–116. doi: 10.1111/cen3.12394. - DOI

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