Company Announcements

TORONTO , June 5, 2025 /CNW/ - Biogen Canada Inc. is disappointed by INESSS's recommendation against listing SKYCLARYS™ (omaveloxolone), despite its therapeutic potential for individuals living with Friedreich ataxia (FA) — a community in urgent need of treatment options.

A decision to not reimburse SKYCLARYS would leave individuals living with FA in Quebec without public access to the only approved treatment for this rare, progressive, and life-shortening neurodegenerative disease – despite a clear and ongoing medical need.¹ As the only approved treatment targeting disease progression, SKYCLARYS addresses a long-standing gap in care for Canadians living with FA, particularly in Quebec where a notable concentration of cases highlights the importance of equitable access.²

"After years of research and failed trials with no approved treatments until now, the availability of a therapy with a demonstrated ability to slow disease progression and preserve mobility is profoundly meaningful for the Friedreich ataxia community, offering renewed hope and the possibility of managing the disease and care in FA. We remain committed to working with INESSS, government authorities, and clinicians to help ensure access to SKYCLARYS for eligible FA patients in Quebec and the rest of Canada," said Eric Tse, General Manager, Biogen Canada.

SKYCLARYS was approved in March 2025 under Health Canada's Priority Review process as the first and only treatment in Canada to target the underlying mechanisms of FA in patients aged 16 and older. Canada'sDrug Agency (CDA-AMC), which advises on drug reimbursement across Canada's public drug programs outside of Quebec, has issued a positive draft recommendation recognizing SKYCLARYS as an important therapeutic option, valued by patients, caregivers, and clinicians for its potential to improve quality of life and preserve function.³

About SKYCLARYS™ (omaveloxolone)
SKYCLARYS™ (omaveloxolone) is an oral, once-daily medication indicated for the treatment of Friedreich ataxia (FA) in adults and adolescents aged 16 years and older in the United States (U.S.), European Union and Canada.^4,5,6  SKYCLARYS received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA).⁵ The European Commission granted Orphan Drug designation in Europe to SKYCLARYS for the treatment of FA.⁶ In Canada, marketing authorization for SKYCLARYS was granted under the Health Canada Priority Review process.⁷

Biogen continues to be dedicated to advancing research and development efforts to enhance the understanding of FA and improve patient outcomes. This includes an ongoing, open-label, Phase 1 study to evaluate the use of SKYCLARYS in in pediatric patients aged 2 to 15 years. More details can be found at clinicaltrials.gov.

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. Ataxia Canada. Friedreich's Ataxia. Available at: https://lacaf.org/en/ataxias/formes-and-transmission/friedreichs-ataxia. Accessed June 2025.
2. McGill Reporter. Tracking Friedreich's Ataxia. Available at: https://reporter.mcgill.ca/tracking-friedrichs-ataxia/. Accessed June 2025.
3. Canada's Drug Agency. Reimbursement review: Omaveloxolone. Available at: https://www.cda-amc.ca/omaveloxolone. Accessed June 2025.
4. SKYCLARYS™ Canadian Product Monograph. Biogen.ca/products/SKYCLARYS_PM_EN
5. U.S. Food and Drug Administration. (2023, February 28) FDA approves first treatment for Friedreich's ataxia [press release] https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia. Accessed June 2025.
6. Biogen Inc. (2024, February 12) Biogen Received European Commission Approval for SKYCLARYS^® (omaveloxolone), the First Therapy to Treat Friedreich's Ataxia [press release] https://investors.biogen.com/news-releases/news-release-details/biogen-received-european-commission-approval-skyclarysr. Accessed June 2025.
7. Health Canada. Priority Review of Drug Submissions (Therapeutic Products) Available at: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/prfs_tpfd-eng.pdf. Accessed June 2025.

SOURCE Biogen Canada Inc.