Santhera to seek conditional approval for idebenone in DMD

Santhera said it will submit an application to EMA next quarter seeking conditional approval of idebenone to treat respiratory dysfunction in patients with Duchenne muscular dystrophy who are not using glucocorticoids.

EMA's CHMP has twice recommended against expanding idebenone's label to include DMD. Santhera Pharmaceuticals Holding AG (SIX:SANN) said the new submission strategy is based on scientific advice from EU regulatory authorities...