Santhera Pharmaceuticals announced that full results from long-term real-world comparative analyses, including baseline data from the ongoing GUARDIAN study of AGAMREE (vamorolone), were presented at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference 2026 in Orlando, Florida. Learn More: What is Agamree (Vamorolone)?
The dataset includes up to eight years of AGAMREE exposure (median approximately five years) in boys with Duchenne muscular dystrophy (DMD). The analyses incorporate data from participants in clinical studies who continued treatment through various access programs as well as the Phase 4 GUARDIAN study (NCT06713135). Long-term data including baseline results from GUARDIAN were compared to a propensity-matched historical control cohort treated with deflazacort or prednisone. (NCT06713135)
Together, the data demonstrate that vamorolone maintains long-term effectiveness comparable to traditional corticosteroids, while improving tolerability and meaningfully reducing key steroid-associated side effects that often lead to dose reductions or discontinuations that impact long-term patient outcomes. Read More: What Are the Pros and Cons of Steroids (Cortisone) for Duchenne
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