Santhera to file FRDA drug in Canada

Swiss drugmaker Santhera Pharmaceuticals says that, following a positive eligibility decision from Health Canada, it intends to file a New Drug Submission in the country seeking approval of SNT-MC17 (idebenone) as a therapy for Friedreich's Ataxia. The agent, which has demonstrated efficacy in the treatment of the neurological and cardiological symptoms of the disease, was recently accepted for review by the European Medicines Agency (EMEA; Marketletter September 3). Klaus Schollmeier, the company's chief executive, said Santhera is "excited about Health Canada's decision," and added that the firm would seek the product's approval with a "safety and efficacy package that is equivalent to the file currently under review at the EMEA."