Health Canada Authorizes ENSPRYNG for Canadians Living with Neuromyelitis Optica Spectrum Disorder
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. 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.
"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, with the disease being most commonly diagnosed among non-Caucasian women in their 20s to 40s. People with NMOSD experience unpredictable, severe relapses causing cumulative, permanent, neurological damage and disability., The condition can be confused with multiple sclerosis (MS), however NMOSD is less common than MS and its attacks can be more severe. 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.,,
"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
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.
About Neuromyelitis Optica Spectrum Disorder
About ENSPRYNG (satralizumab)
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.
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SOURCE Roche Canada