Tags : Puldysa

Santhera Halts P-III SIDEROS Study Evaluating Puldysa in Patients with

Tuba Khan October 6, 2020

Shot: Santhera has discontinued the development of Puldysa (idebenone) in patients with DMD who are in respiratory decline and receive concomitant glucocorticoid treatment. The DSMB has recommended the discontinuation of the SIDEROS study due to futility as it fails to meet its 1EPs i.e. the change of FVC%p from baseline to 18mos. of treatment Following […]Read More

Regulatory

Santhera Reports Submission of Marketing Authorization Application to the EMA

Tuba Khan May 28, 2019

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 […]Read More

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Tags : Puldysa

Santhera Halts P-III SIDEROS Study Evaluating Puldysa in Patients with

Santhera Reports Submission of Marketing Authorization Application to the EMA

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Tags : Puldysa

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