Swissmedic accepts Santhera's filing of SNT-MC17 in Friedreich's Ataxia
Santhera Pharmaceuticals and Takeda Pharma AG announced that Swissmedic has accepted the filing of an application for authorization for Santhera's lead compound SNT-MC17 for the treatment of Friedreich's ataxia (FRDA). SNT-MC17 has shown clinical efficacy in FRDA patients on neurological and cardiac endpoints in several clinical trials and proved to be well tolerated in all studies so far. Upon approval, the product will be marketed in Switzerland by Santhera's partner Takeda. The acceptance of the marketing authorization application in Switzerland follows shortly after the application for marketing authorization in the EU.
The dossier submitted to Swissmedic includes efficacy data generated in the collaborative study with the US National Institutes of Health (NIH) analyzing a variety of neurological and cardiac outcome measures. The file 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. The Swiss application for authorization recommends a starting dose of 450 mg/day for patients below 45 kg body weight and 900 mg/day for patients of 45 kg or above body weight, with the option for the treating physician to use higher doses if needed. The dosing recommendations as well as the data package of the Swiss filing are equivalent to the EMEA filing.
There is an estimated population of 100 to 200 FRDA patients living in Switzerland. An application for orphan drug status has been filed with Swissmedic but will be reviewed independently. Santhera and Takeda believe that the compound has the potential to be granted marketing approval in Switzerland for the treatment of FRDA in the second half of 2008.
Upon marketing approval, SNT-MC17 will be distributed by Takeda Pharma AG. In Switzerland, Takeda has obtained a temporary authorization in May 2004 for its idebenone, which is fully reimbursed to treat cardiomyopathy in FRDA patients. This temporary status will be revoked once SNT-MC17 is approved and Takeda will subsequently switch to Santhera's product.
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