TORONTO, June 16, 2026 /CNW/ – Biogen Canada Inc. is disappointed that negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for SKYCLARYS™ (omaveloxolone) have concluded without reaching an agreement.
The closure of negotiations follows assessments from Health Canada, Canada’s Drug Agency (CDA-AMC) and Quebec’s Institut national d’excellence en santé et en services sociaux (INESSS), which affirmed the therapeutic value of SKYCLARYS, and underscored the significant unmet need faced by people living with Friedreich ataxia (FA) in Canada.
Biogen appreciates the important role of the pCPA in supporting sustainable access to medicines through Canada’s public drug plans. At the same time, this outcome raises important questions about how innovative therapies for rare diseases move from regulatory approval and health technology assessment into the hands of patients.
“For people living with Friedreich ataxia, delays along the path to access are not simply steps in a process–they have real consequences for patients and families facing a relentless disease marked by irreversible decline in function with profound impacts on independence and daily life,” said Eric Tse, General Manager, Biogen Canada. “This outcome underscores a broader challenge across Canada’s healthcare system: ensuring that scientific and therapeutic advances are translated into timely and equitable access for patients, particularly in rare diseases where time is critical. It is essential that access pathways keep pace–and that partners across the healthcare community continue working towards a shared goal of timely patient access to advances recognized by regulators, clinicians and health technology assessment bodies.”
The inability to reach an agreement with the pCPA represents a significant setback for Canadians living with this rare, progressive and life-shortening neurodegenerative disease. Prior to the approval of SKYCLARYS in 2025, patients were reliant on supportive care and symptom management.
Biogen remains committed to the Friedreich ataxia community and to working collaboratively with all stakeholders across the healthcare system to help bring forward sustainable solutions that support public access to this important therapeutic advancement for all eligible Canadians living with FA.
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.
SOURCE Biogen Canada Inc.
