Santhera Seeks EU Authorization for DMD Drug

Santhera Pharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational drug vamorolone for treatment of patients with Duchenne muscular dystrophy (DMD).

The drug candidate binds to the same receptor as corticosteroids — a standard therapy for DMD — but has a different anti-inflammatory action.

The Santhera application includes data from a phase 2b study in which vamorolone met the primary endpoint of “time to stand.”

The investigational drug has received Orphan Drug status, as well as Fast Track and Rare Pediatric Disease designations from the FDA.