Health Canada accepts Santhera's SNT-MC17

Santhera Pharmaceuticals, a Swiss specialty firm focused on neuromuscular diseases, that that Health Canada has validated its filing of a New Drug Submission for SNT-MC17 (idebenone) for the treatment of Friedreich's Ataxia. The compound has shown clinical efficacy in FRDA patients on neurological as well as cardiac endpoints in several clinical studies and proved to be well tolerated in all studies so far. The submission for market authorization in Canada follows shortly after equivalent filings with the European Medicines Agency (EMEA) and Swissmedic.

The dossier submitted to the Therapeutic Products Directorate of Health Canada includes efficacy data generated in the collaborative study with the US National Institutes of Health analyzing a variety of neurological and cardiac outcome measures. The NDS is supported by data from earlier clinical trials in FRDA conducted by academic institutions that demonstrated efficacy primarily in the treatment of the cardiac symptoms of this devastating disease. The safety package consists of data generated by Santhera with SNT-MC17 and Takeda in its earlier preclinical and clinical development program with idebenone, notes Santhera.