Raxone idebenone regulatory update

Santhera said the French National Agency for Medicines and Health Products Safety (ANSM) granted an Authorization of Temporary Use (ATU) for Santhera's Raxone idebenone to treat Leber's hereditary optic neuropathy (LHON). The authorization allows patients in France to receive Raxone before EU approval. Santhera withdrew an MAA for Raxone in March 2013 after EMA's CHMP said the benefits of the compound did not outweigh its risks (see BioCentury, March 25, 2013). The company plans to submit a new MAA this quarter. The MAA will include new efficacy data from an ongoing expanded access program and natural history data collected in collaboration with the European Vision Institute Clinical Research Network. ...