Health Canada Authorizes ENSPRYNG® for Canadians Living with Neuromyelitis Optica Spectrum Disorder

ENSPRYNG is a targeted IL-6R treatment that is administered every four weeks by subcutaneous injection^[1]

MISSISSAUGA, ON, Aug. 31, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today 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.^[1] 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," said Dr. Anthony Traboulsee, Director, MS and NMO Clinic, Djavad Mowfaghian Centre for Brain Health, the University of British Columbia. "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]

"We are pleased that Canadians with NMOSD, one of the allied diseases we support, have an additional option available to manage their disease. Access to new treatments is critical in disease management throughout a person's journey with NMOSD," said Dr. Pamela Valentine, President and CEO, MS Society of Canada.

About the Health Canada Approval
The Health Canada market authorization of ENSPRYNG was based on data from the SAkuraSky and SAkuraStar studies. The SAkuraStar study was a randomized, multicenter, double-blind, placebo-controlled clinical trial to evaluate the effect of ENSPRYNG monotherapy compared to placebo in 95 NMOSD patients from the age of 18 to 74. The SAkuraSky study was a randomized, multicenter, double-blind, placebo-controlled clinical trial that included 83 NMOSD patients, including adolescents from the age of 12 to 74, to evaluate the effect of ENSPRYNG in combination with stable immunosuppressive therapy.^[1] Data from the studies demonstrated the following:

• SAkuraStar: Patients treated with ENSPRYNG achieved a 74 percent reduction in the risk of relapses compared to placebo in the AQP4-IgG seropositive patient population (HR:0.45; 95% CI: 0.23, 0.89; p=0.0184).^[1]
• SAkuraSky: Patients achieved a 79 percent reduction in the risk of relapses in AQP4-IgG seropositive patients when used in combination with baseline therapy compared to baseline therapy plus placebo (HR: 0.38; 95% CI: 0.16, 0.88; p=0.0184).^[1]

In both the SAkuraStar and SAkuraSky studies, the rates of adverse events and serious adverse events were comparable between ENSPRYNG and placebo groups, as monotherapy or in combination with baseline therapy. The most common adverse events in both treatment groups were headache (24.4 and 15.9 per cent), arthralgia (9.8 and 15.9 per cent), and injection related reactions (12.2 and 12.7 per cent). None of the injection related reactions required dose interruption or discontinuation.^[1]

About Neuromyelitis Optica Spectrum Disorder
NMOSD is a demyelinating condition, meaning, it damages the protective myelin sheath around the nerve fibres.^[4]  NMOSD is commonly associated with pathogenic antibodies that target and damage a specific cell type called astrocytes resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain.^[9],[10] AQP4-IgG antibodies are detectable in the blood serum of around two-thirds of NMOSD patients.^[5]

About ENSPRYNG (satralizumab)
ENSPRYNG is a monoclonal antibody that targets the IL-6R receptor, ^[5] which is thought to be a key driver in NMOSD.^[9] People with active NMOSD can have higher levels of IL-6R, so blocking IL-6R signaling is believed to reduce inflammation, dampen production of AQP4-IgG, decrease blood-brain barrier permeability, and prevent astrocyte damage which therefore may limit NMOSD disease activity.^[5],[6],[11]

ENSPRYNG is given by injection under the skin (subcutaneously). The first injection is given under the supervision of a healthcare professional. The first three injections are given once every two weeks and are known as 'loading doses.' After this, the injection is given every four weeks. This is called a 'maintenance dose.' ENSPRYNG is then taken once every four weeks as prescribed by a healthcare professional.^[1]

 About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof, combined with a focus on innovation, have made Roche the leader in personalized healthcare – a strategy that aims to provide patients with timely access to their best possible healthcare solution.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.

Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2020; Hoffmann-La Roche Limited

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.

SOURCE Roche Canada

Jennifer Mota, Roche Canada, T: 437-219-7806, E: [email protected]; Alannah Nugent, Edelman Canada, T: 647-458-3867, E: [email protected]