Santhera Provides Update on Clinical/Regulatory Processes with SNT-MC17/Idebenone for the Treatment of Friedreich's Ataxia

12-Aug-2008

Santhera Pharmaceuticals gave an update on the clinical and regulatory processes surrounding the commercialization of SNT-MC17/idebenone for the treatment of Friedreich's ataxia. The Company requested reexamination of the negative opinion by the CHMP regarding Sovrima® (idebenone), despite the progress of its ongoing Phase III trials. As previously announced, the advanced status of Santhera's Phase III trials appeared to have prevented a review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on the Company's Marketing Authorization Application (MAA) under the EMEA Guideline on clinical trials in Small Populations, as requested upon filing of the MAA in 2007. Meanwhile, Health Canada has published the product monograph of Catena® (idebenone), subsequent to the July 24 approval of the drug to treat symptoms of Friedreich's Ataxia under a Notice of Compliance with Conditions.

Despite the good progress of the ongoing phase III studies, Santhera requested reassessment of the CHMP's initial negative opinion on an EU approval. The Company has 60 days starting from the day of the CHMP opinion to forward detailed grounds for requesting reexamination. For the procedure, the CHMP will appoint a different rapporteur and, as requested by Santhera, consult with a specialist Scientific Advisory Group for specific questions.

In Europe, the MICONOS (Mitochondrial Protection With Idebenone In Cardiac Or Neurological Outcome Study) Phase III trial has currently enrolled 182 patients, i.e. approx. 90% of the patients needed to complete recruitment and is on track for full enrollment in 2008.

In the United States, the IONIA (Idebenone effects On Neurological ICARS Assessments) Phase III trial has currently enrolled 48 patients. It was agreed with the US Food and Drug Administration under a Special Protocol Assessment process to recruit a minimum of 51 patients but to include more patients if available. Given the current prospects for patient availability, Santhera and its US clinical investigators believe that the study can enroll about 60 to 65 patients by early Q4 2008.

https://www.bionity.com/en/news/85629/santhera-provides-update-on-clinical-regulatory-processes-with-snt-mc17-idebenone-for-the-treatment-of-friedreich-s-ataxia.html