Catena® (idebenone) received conditional market approval in Canada for the treatment of Friedreich’s ataxia (FA) in July 2008. Idebenone was among the first antioxidant compounds to be tested in FA. Overall, it has been shown to be safe and well-tolerated in a number of phase 1, 2 and 3 human clinical trials dating back to 1999, with early trials at low doses first appearing to demonstrate the potential for idebenone to reduce FA-associated cardiomyopathy. Now, based on additional data that fails to confirm that treatment with Catena® is beneficial in FA, Santhera Pharmaceuticals has announced it will discontinue sales of the drug on April 30, 2013. The company recently reported that no specific safety issues were identified in connection with removal of Catena® from the market. It also noted that withdrawal of the drug at this time does not preclude the submission of a new application for market authorization for Catena® in the future. The drug is not approved for use in the United States.
