Santhera's Agamree approved by EC for DMD

18 December 2023

Swiss specialty pharma Santhera Pharmaceuticals (SIX: SANN) has announced that Agamree (vamorolone) has been approved in the European Union (EU) to treat Duchenne muscular dystrophy (DMD) in patients four years of age and older, independent of the underlying mutation and ambulatory status.

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.

"Favorable safety and tolerability profile over conventional corticosteroids, including benefits for bone health and growth"Patients who switched from a standard of care corticosteroid to Agamree also maintained the efficacy benefit while recovering their growth and bone health, Santhera stressed.

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