Another Setback For Santhera’s Idebenone DMD Hopes
EU Opinion On Marketing Suitability Is Delayed To Year-End
Santhera needs more time to address concerns regarding its current EU application for idebenone in the DMD setting but the Swiss biotech is keeping its sights on a broader indication.
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Swiss company Santhera's lengthy and problem-laden journey to repurpose its already marketed idebenone for use in Duchenne Muscular Dystrophy has ended in failure. The company has withdrawn its EU filing for the product following its announcement that it was halting development.
Switzerland’s Santhera is to restructure its business and seek extra funding after the failure of Puldysa (idebenone) in a Phase III Duchenne muscular dystrophy study at interim analysis.
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