France grants temporary authorization for Santhera's Raxone

Santhera Pharmaceuticals Holding AG (SIX:SANN) 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 the ubiquinone analog 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. The company plans to submit a new MAA this quarter (see BioCentury Extra, Jan. 18, 2013). ...