08.31.20

Health Canada Authorizes Enspryng for Canadians Living with Neuromyelitis Optica Spectrum Disorder

Source: Roche Canada

Roche Canada announced that Health Canada has granted market authorization for Enspryng (satralizumab) as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive. The treatment is not intended for acute treatment of an NMOSD relapse. Canada is the first country to receive health authority approval for Enspryng, offering a new treatment option for people living with NMOSD.

The Health Canada market authorization of Enspryng was based on data from two phase 3 randomized, multicenter, double-blind, placebo-controlled clinical trials, SAkuraSky and SAkuraStar.[1]

“The impact that NMOSD can have on patients is extensive where even one sudden relapse may result in blindness and paralysis,” Dr. Anthony Traboulsee, Director, MS and NMO Clinic, Djavad Mowfaghian Centre for Brain Health, the University of British Columbia, said in a company news release. “In clinical trials we witnessed the benefits that Enspryng can provide people living with NMOSD in preventing relapses, and I believe this treatment can potentially improve the future outlook of Canadians who live with this serious neurological condition, decreasing the fear and uncertainty of when and how severe their next relapse may be.”

NMOSD is a rare autoimmune disorder of the central nervous system where antibodies can damage the spinal cord and/or optic nerves during attacks. There are approximately 1,000 to 3,000 Canadians living with NMOSD,[2] with the disease being most commonly diagnosed among non-Caucasian women[3] in their 20s to 40s.[4] People with NMOSD experience unpredictable, severe relapses causing cumulative, permanent, neurological damage and disability.[4],[5] The condition can be confused with multiple sclerosis (MS), however NMOSD is less common than MS and its attacks can be more severe.[4] In fact, studies have found that 62 per cent of patients are blind within five to six years of disease onset and approximately 50 per cent of patients need assistance with walking short distances after five years.[6],[7],[8]

REFERENCES

[1]

ENSPRYNG Product Monograph, June 2020.

[2]

Roche Data on File.

[3]

Multiple Sclerosis. Demographic and clinical features of neuromyelitis optica: A review. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4463026/.

[4]

Multiple Sclerosis Society of Canada. Neuromyelitis Optica. Available from: https://mssociety.ca/en/pdf/NMO-EN.pdf.

[5]

Traboulsee A, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. 2020; 19:5; 402-12.

[6]

Kitley J, Leite MI, Nakashima I, et al. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. Brain : a journal of neurology 2012;135:1834-49.

[7]

Kessler RA, Mealy MA, Levy M. Treatment of Neuromyelitis Optica Spectrum Disorder: Acute, Preventive, and Symptomatic. Current treatment options in neurology 2016;18:2.

[8]

Wingerchuk DM, Weinshenker BG. Neuromyelitis optica: clinical predictors of a relapsing course and survival. Neurology 2003;60:848-53.

[9]

Chihara N, Aranami T, Sato W, Miyazaki Y, Miyake S, Okamoto T, et al. Interleukin 6 signalling promotes anti–aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica. Proc Natl Acad Sci USA. 2011; 108: 3701–6.

[10]

Fujihara, K. Neuromyelitis optica spectrum disorders – still evolving and broadening. Curr. Opin. Neurol. 2019;32(3):385-394.

[11]

Hillebrand S, et al. Circulating AQP4-specific autoantibodies alone can induce neuromyelitis optica spectrum disorder in the rat. Acta Neuropathologica. 2019; 137: 467-485.

 

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