ARTICLE | Clinical News

CHMP recommends against Santhera's Raxone for DMD

September 22, 2017 7:52 PM UTC

EMA's CHMP recommended against approving an MAA for Raxone idebenone (SNT-MC17) from Santhera Pharmaceuticals Holding AG (SIX:SANN) to slow down the worsening of breathing function in Duchenne muscular dystrophy (DMD) patients who are not taking corticosteroids. CHMP said the data Santhera provided were insufficient because while Raxone did improve peak expiratory flow compared to placebo, the data showed "no clear improvement in other indicators of breathing function or in muscle strength, motor function or quality of life." The committee also said it had concerns about the way the study was conducted and analyzed, but did not provide details. Santhera said it plans to appeal the recommendation...