Biogen Canada Inc. has announced a significant milestone in the quest for public reimbursement of SKYCLARYS (omaveloxolone) for individuals living with Friedreich ataxia (FA) in Quebec. The Institut national d'excellence en santé et en services sociaux (INESSS) has completed a re-evaluation of the treatment, recognizing its therapeutic value and establishing reimbursement criteria for eligible patients. This development marks a positive step toward making the only approved treatment for FA in Canada accessible through public funding in the province.
Positive Reassessment by INESSS
The INESSS re-evaluation confirms the therapeutic benefits of SKYCLARYS, paving the way for public reimbursement. This outcome follows a positive reimbursement recommendation from Canada's Drug Agency (CDA-AMC) in July 2025. For patients and families affected by Friedreich ataxia, this progress is encouraging, as timely access to treatment is critical for managing this progressive disease.
Expert and Community Perspectives
Dr. Antoine Duquette, a Montreal-based neurologist specializing in FA and inherited neurological disorders, highlighted the importance of this development. "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," he said. "For individuals living with this relentlessly progressive disease, maintaining mobility and independence for longer can have a profound impact on quality of life."
François-Olivier Théberge, General Manager of Ataxia Canada, echoed these sentiments. "For the Friedreich ataxia community, this outcome represents an encouraging and meaningful development. People living with FA and their families continue to face significant physical, emotional, and daily challenges. 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 marks an important milestone."
About Friedreich Ataxia and SKYCLARYS
Friedreich ataxia is a rare, progressive, and life-shortening neurodegenerative disease that affects mobility, coordination, speech, heart function, and daily life. Symptoms typically appear in childhood or adolescence and may include poor coordination, muscle weakness, and fatigue. Many individuals experience severe muscle weakness and difficulty walking, often requiring walking aids or transitioning to a wheelchair within 10 to 20 years of diagnosis. Historically, treatment options were limited to supportive care rather than addressing the underlying disease.
Health Canada granted marketing authorization for SKYCLARYS under Priority Review in March 2025 for the treatment of FA in patients aged 16 years and older. 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.
Looking Ahead
This milestone in Quebec represents a positive step forward for the FA community. With the INESSS re-evaluation supporting reimbursement, eligible patients may soon have improved access to a treatment that can help slow disease progression and preserve function. Biogen Canada continues to work with stakeholders to ensure that SKYCLARYS reaches those who need it most.
