Duchenne candidate Raxone (idebenone)

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May 4, 2016

Santhera Pharmaceuticals has announced a slew of updates in regards to regulatory filings for its Duchenne candidate Raxone (idebenone). The Swiss biotech said it plans to submit “comprehensive briefing material” and a meeting request to the FDA to discuss filing an NDA for DMD patients who are not taking concomitant glucocorticoids. Santhera said it will also submit a new marketing application for Raxone in Duchenne to the EMA. In addition, it’s reporting the launch of a new Phase III (SIDEROS) clinical trial in DMD using glucocorticoids. Patient enrollment will start in coming weeks

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