Health Canada Grants Approval to Santhera’s Agamree for Duchenne Muscular Dystrophy
Toronto, ON – October 6, 2025 – Santhera Pharmaceuticals today announced Health Canada has approved Agamree (vamorolone) as a treatment for Duchenne muscular dystrophy (DMD) in ambulatory patients aged four years and older. This marks the first approved steroidal treatment for DMD in canada designed to preserve muscle function while perhaps mitigating the long-term side effects commonly associated with conventional corticosteroids.
Duchenne muscular dystrophy is a rare, progressive genetic disorder primarily affecting males, causing muscle degeneration and weakness. Agamree’s approval offers a new therapeutic option for Canadian patients, potentially slowing disease progression and improving quality of life. The decision is based on data from pivotal clinical trials demonstrating Agamree’s efficacy in maintaining motor function and its differentiated steroid profile. Santhera anticipates working closely with Canadian health authorities to ensure timely patient access to the treatment.
Agamree functions as a dissociative steroid, meaning it selectively activates glucocorticoid receptors in muscle tissue while minimizing activation in other tissues, potentially reducing systemic side effects like growth suppression and bone density loss. Clinical trials, including the pivotal Phase 2b/3 Vista trial, showed that Agamree maintained motor function as measured by the North Star Ambulatory Duchenne Scale (NSADS) over a 48-week period.
“This approval represents a important step forward for the DMD community in Canada,” stated Thomas Meier, CEO of Santhera. “Agamree offers a novel approach to steroid therapy, with the potential to address the critical need for treatments that balance efficacy and safety.”
Health Canada’s approval follows similar authorizations in the United States and Europe. Santhera is now focused on securing reimbursement and market access to make Agamree available to eligible patients across Canada. Further details regarding availability and pricing will be announced in the coming months.
