Catena idebenone regulatory update

Santhera said it voluntarily withdrew Friedreich's Ataxia drug Catena idebenone from the Canadian market after Health Canada determined that additional clinical data did not confirm the product's effectiveness. The company was required to provide confirmatory evidence of clinical effectiveness of Catena as a condition of approval. Following the withdrawal and the January negative opinion of EMA's CHMP of an MAA for Raxone to treat Leber's hereditary optic neuropathy (LHON), Santhera said it will consider strategic options, including product licensing for the ubiquinone analog in LHON and a possible merger or acquisition (see BioCentury, Jan. 21). The biotech retained Piper Jaffrey to assist in the process and said it has received "expressions of interest" from third parties. ...