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Negative opinion for Raxone (idebenone) in Duchenne muscular dystrophy expected.

Read time: 1 mins
Last updated:25th Jan 2018
Published:25th Jan 2018
Source: Pharmawand

Santhera Pharmaceuticals announced that on 23 January 2018 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, 26 January 2018 as originally announced..

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