Idebenone (under the brand name Catena) in July 2008 received conditional market approval in Canada for the treatment of Friedreich's ataxia (FA). 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 April 30, 2013.
In a Feb. 27, 2013, press release the company 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.
Idebenone was among the first antioxidant compounds to be tested in FA. (Antioxidants are drugs designed to offer some protection against free radical damage in cells and to enhance mitochondrial energy production by rendering free radicals harmless.)
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 (heart muscle abnormality).
Since then, a long history of clinical trials of the drug has produced mixed results. To learn more, read:
Antioxidants don't get at the molecular basis of FA; therefore, they can't cure the disease. However, it's thought that this class of drug may provide some benefit, alone or in combination, with other therapies.