ARTICLE | Company News
EMA reviewing Santhera's Raxone for DMD
June 22, 2016 12:15 AM UTC
Santhera Pharmaceuticals Holding AG (SIX:SANN) said EMA accepted for review an MAA for the company's Raxone idebenone to treat Duchenne muscular dystrophy in patients in whom respiratory function has started to decline and who are not taking concomitant glucocorticoids. The company said it expects a decision from EMA's CHMP in 1Q17.
Raxone is already approved in Europe to treat visual impairment in adolescents and adults with Leber's hereditary optic neuropathy (LHON). ...