Santhera Pharmaceuticals Holding AG announced the launch of AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, respective of the underlying mutation and ambulatory status, in Germany. AGAMREE is the first and only medicinal product for DMD to have received full approval in the EU and, following approval in the U.S. last October and in the UK last week, it is the first authorized treatment for patients with the disease in all three territories. This launch follows the European Commission?s approval of AGAMREE on December 18, 2023, for all 27 EU member states as well as Iceland, Liechtenstein, and Norway.

As part of the marketing authorization, 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. Patients treated with AGAMREE or placebo showed normal and similar growth while growth stunting was observed in children treated with prednisone. In addition, patients who switched from a standard of care corticosteroid to AGAMREE maintained the efficacy benefit while recovering their growth and bone health.