Biogen Canada Inc. has expressed disappointment following the conclusion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for SKYCLARYS (omaveloxolone) without reaching an agreement.
Negotiation Outcome
The closure of negotiations comes after 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 highlighted the significant unmet need for people living with Friedreich ataxia (FA) in Canada.
Biogen's Statement
Eric Tse, General Manager of Biogen Canada, stated: "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."
Tse added: "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."
Impact on Patients
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 relied on supportive care and symptom management.
Biogen's Commitment
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 create value for shareholders and communities. Biogen has been serving Canadian patients for more than 25 years.
