Data from international public/private partnership leads to the first therapy for Duchenne muscular dystrophy approved by both EMA and FDA.

Rockville, MD, USA, December 22, 2023
The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023. The US FDA previously approved AGAMREE for DMD (26 October 2023). This makes AGAMREE the first pharmacological intervention poised to receive full approval for DMD populations in both the US and EU.