BioCentury
ARTICLE | Company News

EMA accepts resubmitted Raxone MAA

June 5, 2014 11:18 PM UTC

Santhera Pharmaceuticals Holding AG (SIX:SANN) said EMA accepted for review a resubmitted MAA for Raxone idebenone to treat Leber's hereditary optic neuropathy (LHON). The company expects a decision in 1H15. 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 resubmitted MAA includes new efficacy data from an ongoing expanded access program for the product as well as natural history data collected in collaboration with the European Vision Institute Clinical Research Network.

Santhera has seen its stock climb about 680% since the start of May on developments in the Duchenne muscular dystrophy (DMD) space, for which the company is also developing idebenone. Santhera plans to submit a regulatory application for idebenone under the name Catena in the U.S. to treat DMD, with a European submission to follow (see BioCentury, May 26). ...