Health Canada Grants Approval to Santhera’s Agamree for Duchenne Muscular Dystrophy
Toronto, ON – October 6, 2025 – Santhera Pharmaceuticals today announcedโ Health Canadaโ has approved Agamree (vamorolone) as a treatment for Duchenne muscular dystrophy โข(DMD) in ambulatory patients โขaged โขfour years and older. This marks the first approved steroidal โtreatment for DMD in canadaโ designed to preserve muscle function while perhaps mitigating the long-term side effects commonly associated with conventional corticosteroids.
Duchenne muscular dystrophy is โขa โขrare, progressive genetic disorder primarily affecting males,โ causing โคmuscle degeneration and weakness. Agamree’s approval offersโ a new therapeutic option for Canadian patients, potentially slowing disease progression and improving quality of life. The decision is based โขon data from pivotal clinical trials demonstrating Agamree’s efficacy in maintaining motor functionโ and its differentiated steroid profile. Santhera anticipates working closelyโฃ with Canadian โขhealth authorities to ensure timely patient access to โฃthe treatment.
Agamree functionsโค as a dissociativeโ steroid, meaning it selectively activates glucocorticoid receptors in muscle tissue while minimizing โคactivation in other tissues, potentiallyโฃ reducing โsystemic side effects like growth suppression and bone โฃdensityโ loss. Clinical trials, including the pivotal Phase 2b/3 โVista trial, showed that Agamreeโ maintained motor function as measured โby the North โฃStar Ambulatory Duchenne Scale (NSADS) over a 48-week period.
“This approvalโข represents a important step forward for the DMD community in Canada,” stated Thomas Meier, CEO of Santhera. “Agamree offers aโฃ novel approach to steroid therapy, with the potential to address the critical โneed for treatments that balance โขefficacy and safety.”
Health Canada’s approval follows similar authorizations in the Unitedโ States and โEurope. Santhera is now focused on securing reimbursement and market access to โmake Agamree available to eligible patients across Canada. Further detailsโค regarding availability and โคpricing will be announced in the coming months.