Friedreich's Ataxia
Santhera Pharmaceuticals (Canada), Inc, the holder of a conditional market authorization (Notice of Compliance with conditions, NOC/c) in Canada for CatenaŽ (Idebenone) in the treatment of Friedreich's Ataxia, has discontinued sales effective April 30, 2013. CatenaŽ had been conditionally authorized in Canada in July 2008 on the basis that it demonstrated promising evidence of clinical efficacy for the treatment of patients with Friedreich's Ataxia. One of the conditions of authorization was to provide confirmatory evidence of this efficacy in further clinical studies. However, the data from the program of studies conducted were not considered by Health Canada to provide such confirmation, and following consultation between Santhera and Health Canada, Santhera has agreed to voluntarily withdraw CatenaŽ from the Canadian market. No specific safety issues were identified that have prompted this action, and the withdrawal does not preclude the submission of a new application for market authorization in the future.