Santhera resubmits Raxone MAA

Santhera Pharmaceuticals Holding AG (SIX:SANN) resubmitted an MAA to EMA for Raxone idebenone to treat Leber's hereditary optic neuropathy (LHON). The company withdrew an MAA for Raxone in March 2013 after EMA's CHMP said the benefits of the compound did not outweigh its risks. The resubmitted MAA includes new efficacy data from an ongoing expanded access program for the ubiquinone analog as well as natural history data collected in collaboration with the European Vision Institute Clinical Research Network. Santhera said it plans to meet with FDA to discuss an approval pathway in the U.S. based on the data package. ...