Pratteln, Switzerland, January 12, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the United Kingdom (UK) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status. The UK’s MHRA, adopting the view of the European Medicines Agency (EMA), acknowledged clinically important safety benefits of AGAMREE with regards to maintaining normal bone metabolism, density and growth compared to standard of care corticosteroids, alongside similar efficacy [1].

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Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom