Santhera Announces Proposed Inclusion and Reimbursement of AGAMREE® (Vamorolone) within Spain’s National Health System for the Treatment of Duchenne Muscular Dystrophy

Core Viewpoint - Santhera Pharmaceuticals announces that AGAMREE® (vamorolone) has been proposed for inclusion in the pharmaceutical coverage of the Spanish National Health System, making it eligible for reimbursement [1][2]. Group 1: Product Information - AGAMREE® is approved by the European Commission for treating Duchenne muscular dystrophy (DMD) in patients aged 4 and older [3]. - The drug has been available in Spain through a paid named-patient program since mid-2024 [3]. - AGAMREE is positioned as a dissociative anti-inflammatory drug, offering an alternative to existing corticosteroids, with a mechanism that aims to dissociate efficacy from steroid safety concerns [4]. Group 2: Clinical Data - In the pivotal VISION-DMD study, AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment, demonstrating a good safety and tolerability profile [5]. - Commonly reported side effects included cushingoid features, vomiting, weight increase, and irritability, generally of mild to moderate severity [5]. - Unlike corticosteroids, AGAMREE shows no restriction of growth and no negative effects on bone metabolism, as indicated by normal serum markers for bone formation and resorption [6]. Group 3: Market Strategy - The company plans to start making AGAMREE available across various regions in Spain from early in the second quarter of 2026, following the acceptance of the draft resolution by the Directorate-General of Pharmacy [2]. - This announcement is seen as a significant milestone in expanding access to AGAMREE for DMD patients in Europe and globally, following commercial launches in Germany, Austria, and the UK [4].