Santhera Announces Approval in Canada for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy

Core Viewpoint - Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older, marking it as the first approved treatment for DMD in Canada [1][9]. Company Overview - Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing innovative medicines for rare neuromuscular diseases with high unmet medical needs [11]. - Kye Pharmaceuticals holds exclusive Canadian commercial rights to AGAMREE for DMD following a sub-license agreement with Santhera's commercialization partner, Catalyst Pharmaceuticals [2]. Product Information - AGAMREE is a novel drug that binds to the same receptor as glucocorticoids but modifies its downstream activity, potentially dissociating efficacy from steroid safety concerns [5]. - In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo at 24 weeks of treatment, with a p-value of 0.002, and demonstrated a good safety and tolerability profile [6]. Market Context - The Canadian Neuromuscular Disease registry estimates over 800 boys and young men living with DMD in Canada [1]. - AGAMREE is now the sixth independent approval by local health authorities, following approvals in the U.S., Europe, the UK, China, and Hong Kong [3].