By SPC News Staff
The FDA approved vamorolone (Agamree, Santhera Pharmaceuticals) oral suspension for the treatment of Duchenne muscular dystrophy (DMD) in children aged 24 months and older.
The FDA approval of vamorolone 40 mg/mL was based on data from the pivotal phase 2b VISION-DMD study, which was supplemented with safety information collected from three open-label studies, including extension studies (ClinicalTrials.gov Identifier: NCT03439670). In the trials, vamorolone was administered at