Santhera Reports Submission of Marketing Authorization Application to the EMA for Puldysa (Idebenone) in Duchenne Muscular Dystrophy

Shots:

• The MAA submission follows the results of P-II DELPHI study, DELPHI-Extension study, P-III DELOS (1-5) study and SYROS study. The collective studies result demonstrated that Puldysa (idebenone) is showing clinical benefits & long-term efficacy in patients with DMD
• Santhera also plans to submit NDA to the FDA following the completion of P-III SIDEROS study assessing Puldysa (Idebenone) in 266 patients with DMD administering glucocorticoid steroids from 18mos. across 60 sites including Europe, the US and Israel
• Puldysa (Idebenone) is a chemical analog of benzoquinone and a co-factor for quinone oxidoreductase (NQO1) and has received the ODD designation in Europe, the US, Switzerland & Australia and a FT designation by the US FDA

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