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.

Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company committed to developing and commercializing innovative medicines to meet the needs of patients living with rare and other diseases with high unmet medical needs.  Santhera currently has three compounds in seven clinical-stage development programs. Santhera’s vision is to become a leading specialty pharmaceutical company offering therapies for a number of indications in this area of high unmet medical need which includes many orphan indications with no current therapy.

October 4, 2022

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