Santhera to Seek Canadian Market Approval for SNT-MC17 in Friedreich's Ataxia

24-Sep-2007

Santhera Pharmaceuticals announces that, with the recent positive decision from Health Canada on eligibility, the Company will file a New Drug Submission (NDS) for SNT-MC17 (INN: idebenone) for the treatment of Friedreich's ataxia (FRDA). 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 Canadian decision follows shortly after the European Medicines Agency (EMEA) accepted Santhera's filing of a Marketing Authorization Application (MAA) for SNT-MC17 in FRDA.

Following a recent meeting with the Therapeutic Products Directorate (TPD) of Health Canada and after the receipt of the decision on eligibility, Santhera now has 60 days to submit the NDS to the Canadian regulatory authorities. In response to TPD's decision, Santhera will file an application for a Notice of Compliance with Conditions (NOC/c). Health Canada's standard review process calls for a 235 day review target including 35 days for processing and screening. If the review is positive, the TPD will issue a Qualifying Notice for the NOC/c application which indicates that the product is eligible for market approval, subject to certain conditions, which must be agreed upon with TPD at a later point in time.

Based on extrapolated published epidemiology data, there is an estimate of several hundred FRDA patients in Canada. Upon approval, Santhera will market the product by its own. The Company has been granted an exclusive license to a use patent application for Canada filed by INSERM (Institut National de la Santé et Recherche Médicale) for the use of idebenone in FRDA.

https://www.bionity.com/en/news/69992/santhera-to-seek-canadian-market-approval-for-snt-mc17-in-friedreich-s-ataxia.html