EMA rejects Raxone/Catena (Santhera) as a treatment for Leber's Hereditary Optic Neuropathy

Santhera Pharmaceuticals has announced that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone (idebenone) as a potential therapy for Leber's Hereditary Optic Neuropathy (LHON). The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has notified Santhera that a narrow majority of CHMP members deemed Raxone not approvable at this time. Santhera believes that the clinical benefit of Raxone in patients in whom the medical need for treatment was most urgent had not been fully considered and therefore has decided to request a re-examination of the opinion.