Santhera's Raxone granted temporary use in France

Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today that the French National Agency for Medicines and Health Products Safety (ANSM) has granted a temporary authorization for use (ATU) for Raxone (idebenone) in the treatment of Leber's Hereditary Optic Neuropathy (LHON).

The ATU system allows patients in France to receive reimbursed treatment with a product before a marketing authorization is granted in the European Union. Promising treatments that have not yet been granted a marketing authorization but where the benefit/risk balance is presumed to be positive, based on the submitted dossier, can be granted a cohort ATU where there is a genuine public health need in the absence of any suitable therapeutic alternative.

The temporary authorization for Raxone was granted after an assessment by the ANSM and clinical experts of a full application dossier comprising quality, clinical efficacy and safety data, including new efficacy data collected from LHON patients participating in an ongoing Expanded Access Program. Santhera will provide Raxone to LHON patients in France under the cohort ATU, for which government allocation to hospitals ensures reimbursement, until a full marketing authorization is granted in the EU.