Drug news
EU approves Raxone (idebenone), to treat visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON)- Santhera Pharma
Santhera Pharmaceuticals announces the European Commission (EC) has granted marketing authorization for Raxone (idebenone) as the first approved medicine available in all 28 member states of the European Union (EU), Norway, Iceland and Liechtenstein for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON). This rare condition is an inherited mitochondrial disease which if untreated usually leads to rapid, profound and permanent blindness in otherwise healthy patients.
Comment:Santhera said it expects to launch Raxone in Europe in the next few weeks, and that it plans to file the drug for approval in Duchenne Muscular Dystrophy in the US ( as Catena) and EU later this year.