Catena® is approved by Health Canada under a Notice of Compliance with Conditions and is marketed for the symptomatic treatment of Friedreich’s Ataxia. In Europe, the European Medicines Agency (EMA) is currently reviewing Santhera’s Marketing Authorization Application for the drug as a first-ever treatment for Leber’s Hereditary Optic Neuropathy (LHON). A decision is expected in the second half of 2012. Santhera is also conducting a phase III randomized and placebo controlled clinical study to investigate the safety and efficacy of Idebenone in Duchenne Muscular Dystrophy (ClinicalTrials.gov Identifier NCT01027884). Study centers are located in Europe and in the United States of America. In addition, clinical trials are ongoing in MELAS syndrome (NCT00887562) at Columbia University in New York City and in Primary Progressive Multiple Sclerosis conducted by the US National Institute of Neurological Disorders and Stroke (NCT00950248). In order to obtain access to Catena® patients or healthcare professionals should contact Masters Pharmaceuticals Limited: Email: ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■; Phone: +1 800 969 1152; Fax: +1 800 969 1153
Fantastic news Alan
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