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Santhera Hopeful On EU DMD Indication Extension

 
• By Neena Brizmohun

Santhera is set to address questions that EU regulators have regarding its application to market Raxone for Duchenne muscular dystrophy.

Blister Packs
European regulators are assessing Raxone for DMD

Santhera Pharmaceuticals is hoping this week to provide EU regulators with the information they need to recommend that the company’s drug, Raxone (idebenone), be approved in the EU for the additional indication of Duchenne muscular dystrophy (DMD).

Santhera will address the European Medicines Agency’s key scientific committee, the CHMP, on Sept. 13, just two days after the...

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