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

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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