Sarepta Therapeutics is to seek full approval for its Duchenne gene therapy Elevidys in the US and partners Roche have likewise vowed to seek approval in ex-US countries, despite it failing to hit the primary endpoint of its Phase III study.
Sarepta And Roche Press Ahead With Elevidys Filing Despite Duchenne Trial Miss
The Phase III EMBARK study has fallen short on its primary endpoint – but Sarepta believes the trial has otherwise produced robust data, and believes a full US approval is justified.
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