Santhera Pharmaceuticals anticipates Receiving a Negative CHMP Opinion on Appeal for Marketing Authorization Application for Raxone® in Duchenne Muscular Dystrophy.
Liestal, Switzerland, January 24, 2018 – Santhera Pharmaceuticals (SIX: SANN) announces that on January 23 it had an oral explanation at the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in relation to the re-examination of its Marketing Authorization Application (MAA) for Raxone® (idebenone) in Duchenne muscular dystrophy (DMD). The company now anticipates that the CHMP will maintain its original position to issue a negative opinion on Santhera’s MAA filed as Type II variation of its existing marketing authorization for Leber’s hereditary optic neuropathy (LHON).
Santhera will provide further update on Friday, January 26, as originally announced.
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