New Progress Toward Public Reimbursement of SKYCLARYS™ for People Living with Friedreich Ataxia in Quebec

• INESSS reassessment supports the therapeutic value of SKYCLARYS and advances the reimbursement pathway for eligible patients in Quebec.

TORONTO, June 8, 2026 /CNW/ - Biogen Canada Inc. is pleased to announce a positive outcome from the Institut national d'excellence en santé et en services sociaux (INESSS) re-evaluation of SKYCLARYS™ (omaveloxolone), recognizing the therapeutic value of the treatment and establishing reimbursement criteria for eligible patients living with Friedreich ataxia (FA) in Quebec. This outcome represents a positive step toward public reimbursement in the province for the only approved treatment in Canada for Friedreich ataxia.

FA is a rare, progressive, and life-shortening neurodegenerative disease that can affect mobility, coordination, speech, heart function and daily life. Despite the significant burden of the disease, treatment approaches for individuals living with FA have historically been limited to supportive care rather than addressing the disease.

"After years without approved treatment options for Friedreich ataxia, the recognition of a therapy that may help slow disease progression and help preserve function represents a significant development for clinicians and the FA community," said Dr. Antoine Duquette, Montreal-based neurologist specializing in Friedreich ataxia and inherited neurological disorders. "For individuals living with this relentlessly progressive disease, maintaining mobility and independence for longer can have a profound impact on quality of life. Progress toward bringing treatment within reach for eligible patients in Quebec is therefore especially significant."

Health Canada granted marketing authorization for SKYCLARYS under Priority Review in March 2025 for the treatment of Friedreich ataxia in patients aged 16 years and older.¹ The approval was based on findings from the Phase II MOXIe Part 2 trial, which demonstrated a statistically significant difference in neurological progression compared to placebo as measured by the modified Friedreich Ataxia Rating Scale (mFARS), a tool used to assess neurological function and disease progression.¹

This important milestone in Quebec follows a positive reimbursement recommendation for SKYCLARYS from Canada's Drug Agency (CDA-AMC) in July 2025.²

"For the Friedreich ataxia community, this outcome represents an encouraging and meaningful development," said François-Olivier Théberge, General Manager of Ataxia Canada. "People living with FA and their families continue to face significant physical, emotional, and daily challenges associated with this progressive disease. Given the comparatively higher number of individuals affected by Friedreich's ataxia in Quebec, recognition of the therapeutic value of SKYCLARYS and movement toward public reimbursement in the province marks an important milestone for individuals living with this progressive disease, for whom timely access to treatment is critical."

Friedreich ataxia symptoms typically appear in childhood or adolescence and may include poor coordination, muscle weakness and fatigue, with many people experiencing severe muscle weakness and difficulty walking that can require walking aids or a transition to a wheelchair within 10 to 20 years of diagnosis. ^{3, 4}

"We are encouraged by INESSS's recognition of the therapeutic value of SKYCLARYS and the urgent unmet need within the Friedreich ataxia community," said Eric Tse, General Manager, Biogen Canada. "This decision marks further progress toward reimbursement for SKYCLARYS in Canada and brings treatment closer to people living with FA. We remain committed to working with governments, clinicians, and the patient community to help improve access for eligible people across Canada as quickly as possible."

Further information regarding the INESSS re-evaluation outcome and reimbursement criteria for SKYCLARYS is available on the INESSS website.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth.

Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca. 

References:

1. SKYCLARYS™ Canadian Product Monograph. Biogen.ca/products/SKYCLARYS_PM_EN
2. Canada's Drug Agency. Reimbursement Recommendation: Omaveloxolone (Skyclarys). Available at: https://www.cda-amc.ca/sites/default/files/DRR/2025/SR0864-Skyclarys_Rec.pdf. Accessed May 2026.
3. Fogel BL, Perlman S. Clinical features and molecular genetics of autosomal recessive cerebellar ataxias. Lancet Neurol. 2007 Mar;6(3):245-57. doi: 10.1016/S1474-4422(07)70054-6. PMID: 17303531. 
4. National Institute of Neurological Disorders and Stroke. Friedreich Ataxia. Available at: https://www.ninds.nih.gov/health-information/disorders/friedreich-ataxia. Accessed May 2026. 

SOURCE Biogen Canada Inc.