EMEA maintains negative opinion on Santhera's idebenone
Switzerland's Santhera Pharmaceuticals says that the European Medicines Agency (EMEA) has informally advised that it would maintain its negative opinion on the Marketing Authorization Application for SNT-MC17/idebenone in Friedreich's Ataxia.
According to the information received, the Committee for Medicinal Products for Human Use (CHMP) of the EMEA concluded in its re-examination that it cannot support an early approval at this point in time, but rather prefers to wait until additional data from at least one of Santhera's two pivotal trials become available for review.
Company chief executive Klaus Schollmeier said: "the confirmation of the original CHMP opinion is obviously a disappointment, but not a surprise."
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