EMA's CHMP rebuffs Santhera's Raxone for DMD a second time

EMA’s CHMP for the second time recommended against expanding the label of Raxone idebenone from Santhera Pharmaceuticals Holding AG (SIX:SANN) to include slowing the loss of breathing function in patients with Duchenne Muscular Dystrophy (DMD).

Santhera had appealed a September decision from the committee recommending against the label expansion. In September, CHMP said that while Raxone did improve peak expiratory flow compared to placebo, supporting data showed "no clear improvement in other indicators of breathing function or in muscle strength, motor function or quality of life" (see BioCentury, Nov. 30, 2017)...