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Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy


Santhera Pharmaceuticals announces that it has submitted a marketing authorization application (MAA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) to the European Medicines Agency (EMA). Santhera is seeking conditional marketing authorization (CMA).

The indication for Puldysa sought under CMA is the treatment of respiratory dysfunction in patients with DMD who are not using glucocorticoids. The MAA is supported by data from Santhera’s Phase II (DELPHI) study, the long-term DELPHI-Extension study, the pivotal Phase III (DELOS) study [1-5] and the recently completed SYROS study, a collection of long-term data from patients who completed the DELOS study and continued to be treated with idebenone for up to six years [6]. 

Santhera Submits Marketing Authorization Application To The European Medicines Agency For Puldysa® (Idebenone) In Duchenne Muscular Dystrophy