3 October 2022 - Santhera Pharmaceuticals announces that the Company has submitted a marketing authorisation application to the EMA for vamorolone for the treatment of Duchenne muscular dystrophy.

At the core of the submission are positive data from the pivotal Phase 2b VISION-DMD trial which comprised a 24 week period to demonstrate efficacy and safety of vamorolone (2 and 6 mg/kg/day) versus prednisone (0.75 mg/kg/day) and placebo, followed by a 24 week period to evaluate the maintenance of efficacy and collect additional longer-term safety and tolerability data.

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